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4. The Italian dementia with Lewy bodies study group (DLB-SINdem): toward a standardization of clinical procedures and multicenter cohort studies design

Author

Bonanni, L., Cagnin, A., Agosta, F., Babiloni, C., Borroni, B., Bozzali, M., Bruni, A. C., Filippi, M., Galimberti, D., Monastero, R., Muscio, C., Parnetti, L., Perani, D., Serra, L., Silani, V., Tiraboschi, P., Padovani, A., Alberici, A., Alberoni, M., Amici, S., Appollonio, I., Arena, M.G., Arighi, A., Avanzi, S., Bagella, C.F., Baglio, F., Barocco, F., Belardinelli, N., Bonuccelli, U., Bottini, G., Bruno Bossio, R., Bruno, G., Buccomino, D., Cacchiò, G., Calabrese, E., Campanelli, A., Canevelli, M., Canu, E.D.G., Cappa, A., Capra, C., Carapelle, E., Caratozzolo, S., Carbone, G.F.S., Cattaruzza, T., Cerami, C., Cester, A., Cheldi, A., Cherchi, R., Chiari, A., Cirafisi, C., Colao, R., Confaloni, A., Conti, M.Z., Costa, A., Costa, B., Cotelli, M.S., Cova, I., Cravello, L., Cumbo, E., Cupidi, C., De Togni, L., Del Din, G., Del Re, M.L., Dentizzi, C., Di Lorenzo, F., Di Stefano, F., Dikova, N., Farina, E., Floris, G., Foti, A., Franceschi, M., Fumagalli, G.G., Gabelli, C., Ghidoni, E., Giannandrea, D., Giordana, M.T., Giorelli, M., Giubilei, F., Grimaldi, L., Grimaldi, R., Guglielmi, V., Lanari, A., Le Pira, F., Letteri, F., Levi Minzi, G.V., Lorusso, S., Ludovico, L., Luzzi, S., Maggiore, L., Magnani, G., Mancini, G., Manconi, F.M., Manfredi, L., Maniscalco, M., Marano, P., Marcon, M., Marcone, A., Marra, C., Martorana, A., Mascia, M.G., Mascia, V., Mauri, M., Mazzei, B., Meloni, M., Merlo, P., Messa, G., Milia, A., Monacelli, F., Montecalvo, G., Moschella, V., Mura, G., Nemni, R., Nobili, F., Notarelli, A., Di Giacomo, R., Onofrj, M., Paci, C., Padiglioni, C., Perini, M., Perotta, D., Perri, Formenti A., Perri, R., Piccininni, C., Piccoli, T., Pilia, G., Pilotto, A., Poli, S., Pomati, S., Pompanin, S., Pucci, E., Puccio, G., Quaranta, D., Rainero, I., Rea, G., Realmuto, S., Riva, M., Rizzetti, M.C., Rolma, G., Rozzini, L., Sacco, L., Saibene, F.L., Scarpini, E., Sensi, S., Seripa, D., Sinforiani, E., Sorbi, S., Sorrentino, G., Spallazzi, M., Stracciari, A., Talarico, G., Tassinari, T., Thomas, A., Tiezzi, A., Tomassini, P.F., Trebbastoni, A., Tremolizzo, L., Tripi, G., Ursini, F., Vaianella, L., Valluzzi, F., Vezzadini, G., Vista, M., Volontè, M.A., On behalf of DLB-SINdem study group, and Istituto Superiore di Sanità

Published
2017
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10. The Italian dementia with Lewy bodies study group (DLB-SINdem): toward a standardization of clinical procedures and multicenter cohort studies design

Author

Bonanni, L, Cagnin, A., Agosta, F., Babiloni, C., Borroni, B., Bozzali, M., Bruni, A. C., Filippi, M., Galimberti, D., Monastero, R., Muscio, C., Parnetti, L., Perani, D., Serra, L., Silani, V., Tiraboschi, P., Padovani, A., On behalf of DLB SINdem study group, Null, Alberici, A., Alberoni, M., Amici, S., Appollonio, I., Arena, M. G., Arighi, A., Avanzi, S., Bagella, C. F., Baglio, F., Barocco, F., Belardinelli, N., Bonuccelli, U., Bottini, G., Bruno Bossio, R., Bruno, G., Buccomino, D., Cacchiò, G., Calabrese, E., Campanelli, A., Canevelli, M., Canu, E. D. G., Cappa, A., Capra, C., Carapelle, E., Caratozzolo, S., Carbone, G. F. S., Cattaruzza, T., Cerami, C., Cester, A., Cheldi, A., Cherchi, R., Chiari, A., Cirafisi, C., Colao, R., Confaloni, A., Conti, M. Z., Costa, A., Costa, B., Cotelli, M. S., Cova, I., Cravello, L., Cumbo, E., Cupidi, C., De Togni, L., Del Din, G., Del Re, M. L., Dentizzi, C., Di Lorenzo, F., Di Stefano, F., Dikova, N., Farina, E., Floris, G., Foti, A., Franceschi, M., Fumagalli, G. G., Gabelli, C., Ghidoni, E., Giannandrea, D., Giordana, M. T., Giorelli, M., Giubilei, F., Grimaldi, L., Grimaldi, R., Guglielmi, V., Lanari, A., Le Pira, F., Letteri, F., Levi Minzi, G. V., Lorusso, S., Ludovico, L., Luzzi, S., Maggiore, L., Magnani, G., Mancini, G., Manconi, F. M., Manfredi, L., Maniscalco, M., Marano, P., Marcon, M., Marcone, A., Marra, C., Martorana, A., Mascia, M. G., Mascia, V., Mauri, M., Mazzei, B., Meloni, M., Merlo, P., Messa, G., Milia, A., Monacelli, F., Montecalvo, G., Moschella, V., Mura, G., Nemni, R., Nobili, F., Notarelli, A., Di Giacomo, R., Onofrj, M., Paci, C., Padiglioni, C., Perini, M., Perotta, D., Perri, Formenti A., Perri, R., Piccininni, C., Piccoli, T., Pilia, G., Pilotto, A., Poli, S., Pomati, S., Pompanin, S., Pucci, E., Puccio, G., Quaranta, D., Rainero, I., Rea, G., Realmuto, S., Riva, M., Rizzetti, M. C., Rolma, G., Rozzini, L., Sacco, L., Saibene, F. L., Scarpini, E., Sensi, S., Seripa, D., Sinforiani, E., Sorbi, S., Sorrentino, Giuseppe, Spallazzi, M., Stracciari, A., Talarico, G., Tassinari, T., Thomas, A., Tiezzi, A., Tomassini, P. F., Trebbastoni, A., Tremolizzo, L., Tripi, G., Ursini, F., Vaianella, L., Valluzzi, F., Vezzadini, G., Vista, M., Volontè, M. A., Bonanni, L, Cagnin, A, Agosta, F, Babiloni, C, Borroni, B, Bozzali, M, Bruni, A, Filippi, M, Galimberti, D, Monastero, R, Muscio, C, Parnetti, L, Perani, D, Serra, L, Silani, V, Tiraboschi, P, Padovani, A, Alberici, A, Alberoni, M, Amici, S, Appollonio, I, Arena, M, Arighi, A, Avanzi, S, Bagella, C, Baglio, F, Barocco, F, Belardinelli, N, Bonuccelli, U, Bottini, G, Bruno Bossio, R, Bruno, G, Buccomino, D, Cacchiò, G, Calabrese, E, Campanelli, A, Canevelli, M, Canu, E, Cappa, A, Capra, C, Carapelle, E, Caratozzolo, S, Carbone, G, Cattaruzza, T, Cerami, C, Cester, A, Cheldi, A, Cherchi, R, Chiari, A, Cirafisi, C, Colao, R, Confaloni, A, Conti, M, Costa, A, Costa, B, Cotelli, M, Cova, I, Cravello, L, Cumbo, E, Cupidi, C, de Togni, L, Del Din, G, Del Re, M, Dentizzi, C, Di Lorenzo, F, Di Stefano, F, Dikova, N, Farina, E, Floris, G, Foti, A, Franceschi, M, Fumagalli, G, Gabelli, C, Ghidoni, E, Giannandrea, D, Giordana, M, Giorelli, M, Giubilei, F, Grimaldi, L, Grimaldi, R, Guglielmi, V, Lanari, A, Le Pira, F, Letteri, F, Levi Minzi, G, Lorusso, S, Ludovico, L, Luzzi, S, Maggiore, L, Magnani, G, Mancini, G, Manconi, F, Manfredi, L, Maniscalco, M, Marano, P, Marcon, M, Marcone, A, Marra, C, Martorana, A, Mascia, M, Mascia, V, Mauri, M, Mazzei, B, Meloni, M, Merlo, P, Messa, G, Milia, A, Monacelli, F, Montecalvo, G, Moschella, V, Mura, G, Nemni, R, Nobili, F, Notarelli, A, Di Giacomo, R, Onofrj, M, Paci, C, Padiglioni, C, Perini, M, Perotta, D, Perri, F, Perri, R, Piccininni, C, Piccoli, T, Pilia, G, Pilotto, A, Poli, S, Pomati, S, Pompanin, S, Pucci, E, Puccio, G, Quaranta, D, Rainero, I, Rea, G, Realmuto, S, Riva, M, Rizzetti, M, Rolma, G, Rozzini, L, Sacco, L, Saibene, F, Scarpini, E, Sensi, S, Seripa, D, Sinforiani, E, Sorbi, S, Sorrentino, G, Spallazzi, M, Stracciari, A, Talarico, G, Tassinari, T, Thomas, A, Tiezzi, A, Tomassini, P, Trebbastoni, A, Tremolizzo, L, Tripi, G, Ursini, F, Vaianella, L, Valluzzi, F, Vezzadini, G, Vista, M, Volontè, M, Bruni, Ac, DLB-SINdem study, Group, Bruni, AC, and Padovani, A - On behalf of DLB-SINdem study group

Subjects
Lewy Body Disease, medicine.medical_specialty, Pediatrics, Dementia with Lewy bodie, Dementia with Lewy bodies, Dermatology, Cohort Studies, Diagnosis, Differential, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Alzheimer Disease, Surveys and Questionnaires, mental disorders, Standardization of diagnostic procedures, Diagnosis, Survey, Disease Management, Humans, Italy, Research Design, 2708, Neurology (clinical), Psychiatry and Mental Health, medicine, Dementia, 030212 general & internal medicine, MED/01 - STATISTICA MEDICA, MED/26 - NEUROLOGIA, business.industry, Standardization of diagnostic procedure, General Medicine, medicine.disease, Settore MED/26 - NEUROLOGIA, Cohort, Differential, Physical therapy, Delirium, Alzheimer's disease, medicine.symptom, business, 030217 neurology & neurosurgery, Frontotemporal dementia, Cohort study
Abstract

Dementia with Lewy bodies (DLB) causes elevated outlays for the National Health Systems due to high institutionalization rate and patients' reduced quality of life and high mortality. Furthermore, DLB is often misdiagnosed as Alzheimer's disease. These data motivate harmonized multicenter longitudinal cohort studies to improve clinical management and therapy monitoring. The Italian DLB study group of the Italian Neurological Society for dementia (SINdem) developed and emailed a semi-structured questionnaire to 572 national dementia centers (from primary to tertiary) to prepare an Italian large longitudinal cohort. The questionnaire surveyed: (1) prevalence and incidence of DLB; (2) clinical assessment; (3) relevance and availability of diagnostic tools; (4) pharmacological management of cognitive, motor, and behavioural disturbances; (5) causes of hospitalization, with specific focus on delirium and its treatment. Overall, 135 centers (23.6 %) contributed to the survey. Overall, 5624 patients with DLB are currently followed by the 135 centers in a year (2042 of them are new patients). The percentage of DLB patients was lower (27 ± 8 %) than that of Alzheimer's disease and frontotemporal dementia (56 ± 27 %) patients. The majority of the centers (91 %) considered the clinical and neuropsychological assessments as the most relevant procedure for a DLB diagnosis. Nonetheless, most of the centers has availability of magnetic resonance imaging (MRI; 95 %), electroencephalography (EEG; 93 %), and FP-CIT single photon emission-computerized tomography (SPECT; 75 %) scan for clinical applications. It will be, therefore, possible to recruit a large harmonized Italian cohort of DLB patients for future cross-sectional and longitudinal multicenter studies.

Published
2017

11. Evaluation of the diagnostic accuracy of three memory tests for early Alzheimer's disease (pe-2013-02356465) : a preliminary report

Author

Brambilla, M, Bottoni, D, Maggiore, L, Cova, I, Alemanno, F, Logie, R, Iannaccone, S, Cappa, S, Pantoni, L, Parra Rodriguez, MA, Della Sala, S, and Pomati, S

Subjects
RC0321
Abstract

Aims: The main aim of this multicentric longitudinal project is to investigate the specificity and sensitivity of three memory tests (FCSRT, STMBT, DMS48) proposed as cognitive marker for Alzheimer's disease (AD). Here, we report preliminary baseline data on healthy controls, people with MCI and patients with AD. Subjects and methods: Data collected on 13 AD, 16 MCI, 16 healthy older (HO) and 16 healthy younger (HY) adults were analysed. All participants underwent the three experimental tests along with a standard neuropsychological evaluation in one single session. Results: For the FCSRT, a three-way ANOVA with GROUP as the between-subjects factor and TASK (free, cued) and TIME (immediate, delayed) as within-subjects measures revealed a significant effect of GROUP (HY = HO > MCI > AD; p< .001), TASK (cued > free, ; p< .001), TIME (immediate > delayed; p< .001), and a significant interaction between GROUP and TASK (p< .001). For the DMS48, a three-way ANOVA with GROUP as the between-subjects factor and STIMULUS (paired, abstract, unpaired) and TIME (immediate, delayed) as within-subjects measures revealed a significant effect of GROUP (HY = HO > MCI > AD; p< .001), STIMULUS (unpaired > paired = abstract; p< .001) and a significant interaction between GROUP and STIMULUS (p< . 001). For the STMBT a three-way ANOVA with GROUP as the between-subjects factor and STIMULUS (2 or 3 items) and TASK (shape only, binding) as within-subjects measures revealed a significant effect of GROUP (HY > HO > MCI > AD; p < .001), STIMULUS (2 > 3; p< .001) and TASK (shape > binding; p< .001) and a significant interaction between STIMULUS and GROUP (p= .003). Discussion: The present report study shows reports for the first time a comparison across Controls, MCI and AD on three memory tests proposed as cognitive markers for AD. For the FCSRT both the timing of recall and the presence of a cue are relevant factors to influence patient performances. For the DMS48 the most sensitive indexes to differentiate between controls and patients are the unpaired and abstract items, while for the STMBT the binding condition is more affected in patients are regardless of the number of items presented are. These preliminary data are encouraging in confirming that these tests may offer an aid to diagnosis of early AD, but a larger sample and longitudinal data are needed to address the main research question of this planned study. *** References: Barbeau, E, Didic, M, Tramoni, E, Felician, O, Joubert, S, Sontheimer, A, Ceccaldi, M, Poncet, M. (2004). Evaluation of visual recognition memory in MCI patients. Neurology 62, 1317-1322. Frasson P, Ghiretti R, Catricala E, Pomati S, Marcone A, Parisi L, Rossini PM, Cappa SF, Mariani C, Vanacore N, Clerici F (2011) Free and cued selective reminding test: an Italian normative study. Neurological Sciences 32:1057-1062 Parra MA, Abrahams S, Fabi K, Logie R, Luzzi S, Della Sala S (2009) Short-term memory binding deficits in Alzheimer's disease. Brain 132:1057-1066

Published
2018

13. Supplementary Material for: Does Vascular Burden Contribute to the Progression of Mild Cognitive Impairment to Dementia?

Author

Clerici, F., Caracciolo, B., Cova, I., Fusari Imperatori, S., Maggiore, L., Galimberti, D., Scarpini, E., Mariani, C., and Fratiglioni, L.

Subjects
mental disorders
Abstract

Aims: To investigate the contribution of vascular risk factors (VRFs), vascular diseases (VDs) and white matter lesions (WMLs) to the progression of mild cognitive impairment (MCI) to dementia and Alzheimer’s disease (AD). Methods: Two hundred forty-five consecutive subjects with MCI (age 74.09 ± 6.92 years) were followed for an average of 2.4 years. The Hachinski Ischemic Score and the Framingham Stroke Risk Profile were used to summarize VRFs and VDs. WMLs were graded using the Age-Related White Matter Changes Scale. Results: One hundred twenty-nine (52.6%) out of 245 subjects at risk converted to dementia, including 87 cases of AD. When hypertension occurred in MCI with deep WMLs, a 1.8-fold increased risk of dementia was observed (95% CI = 1.0–3.4). When deep WMLs occurred in MCI with high scores (≥4) on the Hachinski scale, a 3.5-fold (95% CI = 1.6–7.4) and 3.8-fold (95% CI = 1.2–11.5) risk of progression to dementia and AD was observed, respectively. Analogously, the joint effect of WMLs and high scores (≥14) on the Framingham scale nearly doubled the risk of dementia (hazard ratio = 1.9, 95% CI = 1.1–3.3). Conclusions: Accelerated progression of MCI to dementia and AD is to be expected when VRFs and VDs occur together with WMLs.

Published
2017
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14. Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study

Author

Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, Altavilla, R, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, Avanzi, S, Bargnani, C, Bascelli, C, BELLELLI, GIUSEPPE, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, PL, Magnani, G, Schiatti, E, Marcone, A, Giusti, MC, Margarito, FP, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, CN, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, GP, Manzoni, L, Saviotti, FM, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, and Alberici, A

Subjects
Male, medicine.medical_specialty, Postmarketing surveillance, Severity of Illness Index, law.invention, Demenza, malattia di Alzheimer, Randomized controlled trial, law, Alzheimer Disease, Memantine, Internal medicine, medicine, Product Surveillance, Postmarketing, Dementia, Humans, Pharmacology (medical), Adverse effect, Aged, MED/26 - NEUROLOGIA, Aged, 80 and over, Psychiatric Status Rating Scales, business.industry, Odds ratio, medicine.disease, Surgery, Treatment Outcome, Tolerability, Italy, Clinical Global Impression, Female, Geriatrics and Gerontology, business, Excitatory Amino Acid Antagonists, memantina, medicine.drug
Abstract

Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drug’s effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimer’s disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke — Alzheimer’s Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (mean age 77 ± 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (‘no deterioration’ and ‘improvement’), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) was similar to that reported in two previous randomized clinical trials (10% and 12.4%). This PMS provides additional evidence that both the effectiveness and the tolerability of memantine may be transferred into real world medicine, where AD patients receiving treatment are not selected according to strict criteria.

Published
2009

17. Frequenza e caratteristiche cliniche della cefalea in una popolazione di 386 soggetti HIV sieropositivi. Frequency and clinical characteristics of headache in 386 HIV seropositive subjects

Author

Grassi, MP, Borella, M, Maggiore, L, Mangoni, A., PERIN, CECILIA, Grassi, M, Borella, M, Perin, C, Maggiore, L, and Mangoni, A

Subjects
infezione da HIV, cefalea, epidemiologia, MED/26 - NEUROLOGIA, HIV infection, headache, epidemiology
Abstract

Obiettivo del presente studio è di valutare la frequenza , le caratteristiche cliniche e le cause del sintomo cefalea, nonché la sua collocazione all'interno della storia naturale di malattia in una popolazione di soggetti HIV sieropositivi. A tale scopo sono stati retrospettivamente valutati 386 soggetti; di questi 269 soggetti erano affetti da una patologia cerebrale e 158 (58,7%) presentavano il sintomo cefalea. Dal presente studio emerge che la sintomatologia cefalalgica si presenta, nella popolazione allo studio, associata a patologie HIV correlate nel 58% dei soggetti, come cefalea non associata a patologie HIV-correlate nel 25% e come cefale aidiopatica nel 17%. Si è osservato che le patologie HIV-correlate sono prevalentemente associate a cefalea di tipo gravativo, che si manifesta soprattutto nelle fasi avanzate di malattia; le cefalee non associate a patologie HIV-correlate si manifestano invece sia in forma gravativa che pulsante, coinvolgendo le fasi intermedie di malattia. Infine, tra le forme di cefalea idiopatica, riscontrabile in tutte le fasi di malattia, prevale quella a carattere pulsante. the purpose of the following study is to evaluate the frequency , clinical characteristics and causes of headache, as well as its place in the natural history of the disease in an HIV positive population. Out of 368 HIV positive subjects under neurological observation , who were evaluated consecutively , 158 (58,7%) manifested headache. from this study it has been observed that headache is present in the 58% of the studied population associated with HIV-related pathologies, associated with non HIV-related pathologies in the 25% and as idiopathic headhache in the 17%. it has been observed that HIV-related pathologies are mainly connected to a tension type headache wich manifests it-self particularly in the advanced stages of the illness; the headache associated with non HIV-related pathologies occurs in the intermediate stages of the illness in both migraine and tension types. Finally the migraine type prevails among all of idiopathic headache and it manifests in every stage of the disease.

Published
2001

18. How legislation on decisional capacity can negatively affect the feasibility of clinical trials in patients with dementia

Author

Galeotti, F, Vanacore, N, Gainotti, S, Izzicupo, F, Menniti Ippolito, F, Petrini, C, Chiarotti, F, Chattat, R, Raschetti, R, AdCare Study Group: Popoli, P, Potenza, R, Tebano, Mt, Giubilei, F, Locuratolo, N, Bruno, G, Piacentini, E, Talarico, G, Gasparini, M, Del Re ML, Bruni, A, Colao, R, Puccio, G, Curcio, S, Clodimiro, A, Caffarra, P, Messa, G, Concari, L, Pagliara, B, Fabbo, A, Zucchi, P, Bonora, A, Veschi, M, Carbone, G, Ursino, R, Fatica, L, De Bonis, C, Gainotti, G, Marra, C, Quaranta, D, Zinno, M, Rodriguez, Guido, Nobili, FLAVIO MARIANO, Barbieri, Mp, Dessi, B, Mazzei, D, Arnaldi, Dario, Brugnolo, Andrea, Clerici, F, Mariani, C, Maggiore, L, Pomati, S, Padovani, A, Rozzini, L, Zanetti, M, Conti, M, Chinaglia, C, Engaddi, I, De Domenico, D, Savorgnan, G, Scarpino, O, Civerchia, P, Raccichini, A, Specchio, Lm, Goffredo, R, Biancardi, Me, Putzu, V, Araujo, Y, Ballisai, A, Piras, Mr, Cherchi, R, Bagella, Cf, Deiana, E, Giordano, M, Pineo, A, Catania, Tm, Bracco, L, Piccini, C, Mecocci, P, Feliziani, Ft, Cornacchiola, V, Gambina, G, Broggio, E, Sala, F., Galeotti F, Vanacore N, Gainotti S, Izzicupo F, Menniti-Ippolito F, Petrini C, Chiarotti F, Chattat R, Raschetti R, and AdCare Study Group

Subjects
Olanzapine, medicine.medical_specialty, medicine.drug_class, medicine.medical_treatment, Decision Making, Atypical antipsychotic, law.invention, Randomized controlled trial, Informed consent, law, Humans, Medicine, Mental Competency, Pharmacology (medical), Antipsychotic, Psychiatry, legal, Clinical Trials as Topic, Risperidone, business.industry, Patient Selection, CAPACITY, BPSD, antipsychotic, Clinical trial, Settore MED/26 - NEUROLOGIA, Feasibility Studies, Quetiapine, Dementia, Geriatrics and Gerontology, business, medicine.drug
Abstract

Antipsychotic drugs are widely used to treat behavioural and psychological disturbances associated with Alzheimer's disease (AD), although only modest evidence from randomized controlled trials supports their efficacy, and increasing evidence from post-marketing surveillance shows serious adverse events associated with their use, including increased mortality. The AdCare study, a non-profit, randomized, placebo-controlled, double-blind, multicentre, pragmatic trial coordinated by the Italian National Institute of Health, aimed to evaluate the long-term safety and efficacy profiles of three atypical antipsychotic drugs (risperidone, olanzapine and quetiapine) and one conventional antipsychotic drug (haloperidol) in treating psychosis, aggression and agitation in outpatients with AD. The study was planned to be carried out in 19 clinical centres and to enrol 1000 outpatients. According to Italian law, in the case where a patient is considered unable to give informed consent, a legal representative designated by the court has to provide it. Because of difficulties in the informed consent procedure, the study had to be prematurely interrupted. From February 2009 to April 2010, 83 patients gave informed consent to participate in the trial. Fifty-six patients (68%) were included with consent given by a legal representative, while 27 patients (32%) were considered to provide personal informed consent on the basis of the results from a specifically built procedure. Patients and caregivers were offered the opportunity to participate in the trial before the occurrence of behavioural disturbances, in order to provide them with enough time to consider their participation in the study. Twenty-three patients experienced behavioural, clinically relevant symptoms and were randomized to the study drug; all randomized patients except one had consent for inclusion in the study given by legal representatives. After trial interruption, all patients taking an active drug continued treatment with the same molecule in clinical practice. Randomized controlled trials are acknowledged as the gold standard source of evidence on drug safety and efficacy. The AdCare study showed that an excessively rigid regulation can become a major obstacle while carrying out therapeutic research with incapacitated persons.

Published
2012

19. Memantine effects on behaviour in moderately severe to severe Alzheimer's disease: a post-marketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila-Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, Pl, Magnani, G, Schiatti, E, Marcone, A, Giusti, Mc, Margarito, Fp, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Negri Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petrò, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, Gp, Manzoni, L, Saviotti, Fm, Scarpini, E, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Marcon, Gabriella, and Appollonio, I

Subjects
Male, medicine.medical_specialty, Psychosis, Hallucinations, Behavioural and psychological symptoms of dementia, Apathy, Dopamine Agents, Postmarketing surveillance, Dermatology, Anxiety, Neuropsychological Tests, Logistic regression, Disease cluster, Severity of Illness Index, Alzheimer's disease, Memantine, Post-marketing surveillance study, Alzheimer Disease, Internal medicine, Severity of illness, Product Surveillance, Postmarketing, medicine, Humans, Dementia, Psychiatry, BIO/14 - FARMACOLOGIA, Aged, Aged, 80 and over, MED/26 - NEUROLOGIA, treatment, Depression, Feeding Behavior, General Medicine, medicine.disease, Psychiatry and Mental health, Treatment Outcome, Hypomania, Female, Neurology (clinical), medicine.symptom, Psychology, Follow-Up Studies, dementia, medicine.drug
Abstract

The aim of this study is to evaluate memantine effectiveness on behavioural and psychological symptoms of dementia (BPSD) in clinical practice and to identify variables that may predict the therapy effects. The effects of memantine on behaviour were analysed in the database of a post-marketing surveillance study promoted by the Lombardy Region Health Office and involving 43 Alzheimer's disease (AD) Units. From July to December 2005, 399 moderately severe-to-severe AD patients free of cholinergic medications were enrolled, treated with memantine and followed-up for 6 months. BPSD were assessed in a subgroup of 297 patients [mean age 77 ± 8 years; 73% females; mean neuropsychiatric inventory (NPI) score 28 ± 24] for whom the 12-item NPI subscores at baseline, and at 3 and 6 months were available. The 12 BPSD were clustered as follows: affect, physical behaviour, psychosis and hypomania. The main outcome measure was the proportion of individual cluster responders at 6 months of therapy. The proportion of individual cluster responders was 30% affect, 24% physical behaviour, 29% psychosis, 27% hypomania. Patients taking 20 mg memantine daily during the study period had a statistically significant higher probability to experience behavioural improvement than those who discontinued treatment or did not complete memantine titration (affect OR 9.0; 95% CI 3.8-21.6; physical behaviour OR 17.8; 95% CI 5.9-53.6; psychosis OR 23.6; 95% CI 5.1-110.8). The logistic regression analysis was not applicable to the hypomania subsyndrome because of the low cluster prevalence. The standard 20 mg daily memantine treatment regimen was found to be associated with a modest 6-month behavioural improvement in the affect, physical behaviour and psychosis domains in 24-30% of patients.

Published
2012

20. Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila-Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Negri Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petrò, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, and Alberici, A

Published
2009

22. Memantine in moderately-severe-to-severe Alzheimer's disease: a post-marketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A, Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, BELLELLI, GIUSEPPE, Ratti, PL, Giusti, MC, Margarito, FP, Chinaglia, CN, Salvi, GP, Saviotti, FM, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A, Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, BELLELLI, GIUSEPPE, Ratti, PL, Giusti, MC, Margarito, FP, Chinaglia, CN, Salvi, GP, Saviotti, FM, and Alberici, A.

Abstract

Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drugs effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimers disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke Alzheimers Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (meanage 77 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (no deterioration and improvement), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) w

Published
2009

23. Frequenza e caratteristiche cliniche della cefalea in una popolazione di 386 soggetti HIV sieropositivi. Frequency and clinical characteristics of headache in 386 HIV seropositive subjects

Author

Grassi, M, Borella, M, Perin, C, Maggiore, L, Mangoni, A, Grassi, MP, Mangoni, A., PERIN, CECILIA, Grassi, M, Borella, M, Perin, C, Maggiore, L, Mangoni, A, Grassi, MP, Mangoni, A., and PERIN, CECILIA

Abstract

Obiettivo del presente studio è di valutare la frequenza , le caratteristiche cliniche e le cause del sintomo cefalea, nonché la sua collocazione all'interno della storia naturale di malattia in una popolazione di soggetti HIV sieropositivi. A tale scopo sono stati retrospettivamente valutati 386 soggetti; di questi 269 soggetti erano affetti da una patologia cerebrale e 158 (58,7%) presentavano il sintomo cefalea. Dal presente studio emerge che la sintomatologia cefalalgica si presenta, nella popolazione allo studio, associata a patologie HIV correlate nel 58% dei soggetti, come cefalea non associata a patologie HIV-correlate nel 25% e come cefale aidiopatica nel 17%. Si è osservato che le patologie HIV-correlate sono prevalentemente associate a cefalea di tipo gravativo, che si manifesta soprattutto nelle fasi avanzate di malattia; le cefalee non associate a patologie HIV-correlate si manifestano invece sia in forma gravativa che pulsante, coinvolgendo le fasi intermedie di malattia. Infine, tra le forme di cefalea idiopatica, riscontrabile in tutte le fasi di malattia, prevale quella a carattere pulsante., the purpose of the following study is to evaluate the frequency , clinical characteristics and causes of headache, as well as its place in the natural history of the disease in an HIV positive population. Out of 368 HIV positive subjects under neurological observation , who were evaluated consecutively , 158 (58,7%) manifested headache. from this study it has been observed that headache is present in the 58% of the studied population associated with HIV-related pathologies, associated with non HIV-related pathologies in the 25% and as idiopathic headhache in the 17%. it has been observed that HIV-related pathologies are mainly connected to a tension type headache wich manifests it-self particularly in the advanced stages of the illness; the headache associated with non HIV-related pathologies occurs in the intermediate stages of the illness in both migraine and tension types. Finally the migraine type prevails among all of idiopathic headache and it manifests in every stage of the disease.

Published
2001

25. Considerazioni sulle risultanze statistiche delle malformazioni congenite letali e no in Italia dal 1956 al 1958

Author

Maggiore L

Subjects
Geography, General Medicine, Humanities
Abstract

SUMMARYThe statistical data on the malformation occurred in Italy from 1956 to 1958 have been examined. It has been seen that their number is almost constant (i. e. some 1,500 per year). The ratio of alive malformed to dead malformed is of 3:1, but the number of deaths by congenital malformations increases considerably during the first year of life, mostly due to inner organ malformations, non detectable at birth.50% of the cases of harelip die during the first year of life. The most serious malformations are those concerning the central nervous system, while the most common ones, are those affecting the locomotive apparatus.The number of malformations has not been influenced by the very insufficient diet during the four years of war, neither by the 1957 « asiatic influenza ». The malformation index, furthermore, appears almost constant in the time and in the various regions, showing the highest figure in Lucania and Friuli (3.05) and the lowest ones in Campania (0,89), Sicily and Liguria (1.21).

Published
1963
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26. Differences in hippocampal metabolism between amnestic and non-amnestic MCI subjects: Automated FDG-PET image analysis

Author

Clerici F, Del Sole A, Arturo Chiti, Maggiore L, Lecchi M, Pomati S, Mosconi L, Lucignani G, and Mariani C

Subjects
Lewy Body Disease, Male, Middle Aged, Neuropsychological Tests, Hippocampus, Temporal Lobe, Automation, Glucose, Fluorodeoxyglucose F18, Positron-Emission Tomography, Humans, Female, Amnesia, Cognition Disorders, Aged
Abstract

The aim of this study was to assess whether 18F-fluorodeoxyglucose positron emission tomography differentiates amnestic (aMCI) from single-non-amnestic mild cognitive impairment (snaMCI) with executive dysfunction.Sixteen aMCI subjects (62% females, age 75+/-8 years) and 14 snaMCI subjects (71% females, age 74+/-6 years) underwent [18F]FDG-PET and clinical follow-up. Comparisons between MCI subgroups and with seven cognitively normal elderly subjects were performed using SPM2.At baseline aMCI and snaMCI exhibited a similar pattern of hypometabolism, mostly in the posterior cingulate gyrus, as compared with controls. In the comparison between the MCI subtypes, the aMCI subjects showed reduced metabolism in the medial temporal lobes (MTL) (hippocampus, fusiform gyrus and amygdala). At follow-up 12 aMCI developed Alzheimer's disease (AD), while snaMCI had a heterogeneous course, including five subjects who developed Lewy body dementia.The patterns of altered brain metabolism in aMCI and snaMCI subjects compared to controls are similar and do not provide evidence for making clinical distinctions between them. Comparison between the two MCI subtypes showed MTL hypometabolism in aMCI subjects, possibly reflecting the fact that most had prodromal AD.

28. Prevalence and features of delirium in older patients admitted to rehabilitation facilities

Author

Sidoli, Chiara, Zambon, Antonella, Tassistro, Elena, Rossi, Emanuela, Mossello, Enrico, Inzitari, Marco, Cherubini, Antonio, Marengoni, Alessandra, Morandi, Alessandro, Bellelli, Giuseppe, Tarasconi, A, Sella, M, Paternò, G, Faggian, G, Lucarelli, C, De Grazia, N, Alberto, C, Porcella, L, Nardiello, I, Chimenti, E, Zeni, M, Romairone, E, Minaglia, C, Ceccotti, C, Guerra, G, Mantovani, G, Monacelli, F, Candiani, T, Santolini, F, Rosso, M, Bono, V, Sibilla, S, Dal Santo, P, Ceci, M, Barone, P, Schirinzi, T, Formenti, A, Nastasi, G, Isaia, G, Gonella, D, Battuello, A, Casson, S, Calvani, D, Boni, F, Ciaccio, A, Rosa, R, Sanna, G, Manfredini, S, Cortese, L, Rizzo, M, Prestano, R, Greco, A, Lauriola, M, Gelosa, G, Piras, V, Arena, M, Cosenza, D, Bellomo, A, Lamontagna, M, Gabbani, L, Lambertucci, L, Perego, S, Parati, G, Basile, G, Gallina, V, Pilone, G, Giudice, C, Pietrogrande, L, Mosca, M, Corazzin, I, Rossi, P, Nunziata, V, D’Amico, F, Grippa, A, Giardini, S, Barucci, R, Cossu, A, Fiorin, L, Distefano, M, Lunardelli, M, Brunori, M, Ruffini, I, Abraham, E, Varutti, A, Fabbro, E, Catalano, A, Martino, G, Leotta, D, Marchet, A, Dell’Aquila, G, Scrimieri, A, Davoli, M, Casella, M, Cartei, A, Polidori, G, Brischetto, D, Motta, S, Saponara, R, Perrone, P, Russo, G, Del, D, Car, C, Pirina, T, Franzoni, S, Cotroneo, A, Ghiggia, F, Volpi, G, Menichetti, C, Bo, M, Panico, A, Calogero, P, Corvalli, G, Mauri, M, Lupia, E, Manfredini, R, Fabbian, F, March, A, Pedrotti, M, Veronesi, M, Strocchi, E, Borghi, C, Bianchetti, A, Crucitti, A, Difrancesco, V, Fontana, G, Geriatria, A, Bonanni, L, Barbone, F, Serrati, C, Ballardini, G, Simoncelli, M, Ceschia, G, Scarpa, C, Brugiolo, R, Fusco, S, Ciarambino, T, Biagini, C, Tonon, E, Porta, M, Venuti, D, Delsette, M, Poeta, M, Barbagallo, G, Trovato, G, Delitala, A, Arosio, P, Reggiani, F, Zuliani, G, Ortolani, B, Mussio, E, Girardi, A, Coin, A, Ruotolo, G, Castagna, A, Masina, M, Cimino, R, Pinciaroli, A, Tripodi, G, Cassadonte, F, Vatrano, M, Scaglione, L, Fogliacco, P, Muzzuilini, C, Romano, F, Padovani, A, Rozzini, L, Cagnin, A, Fragiacomo, F, Desideri, G, Liberatore, E, Bruni, A, Orsitto, G, Franco, M, Bonfrate, L, Bonetto, M, Pizio, N, Magnani, G, Cecchetti, G, Longo, A, Bubba, V, Marinan, L, Cotelli, M, Turla, M, Sessa, M, Abruzzi, L, Castoldi, G, Lovetere, D, Musacchio, C, Novello, M, Cavarape, A, Bini, A, Leonardi, A, Seneci, F, Grimaldi, W, Fimognari, F, Bambar, V, Saitta, A, Corica, F, Braga, M, Servi, Null, Ettorre, E, Camellini Bellelli, C G, Annoni, G, Marengoni, A, Crescenzo, A, Noro, G, Turco, R, Ponzetto, M, Giuseppe, L, Mazzei, B, Maiuri, G, Costaggiu, D, Damato, R, Formilan, M, Patrizia, G, Santuar, L, Gallucci, M, Paragona, M, Bini, P, Modica, D, Abati, C, Clerici, M, Barbera, I, Nigroimperiale, F, Manni, A, Votino, C, Castiglioni, C, Di, M, Degl’Innocenti, M, Moscatelli, G, Guerini, S, Casini, C, Dini, D, Denotariis, S, Bonometti, F, Paolillo, C, Riccardi, A, Tiozzo, A, Samysalamafahmy, A, Dibari, M, Vanni, S, Scarpa, A, Zara, D, Ranieri, P, Alessandro, M, Di, F, Pezzoni, D, Platto, C, D’Ambrosio, V, Ivaldi, C, Milia, P, Desalvo, F, Solaro, C, Strazzacappa, M, Cazzadori, M, Grasso, M, Troisi, E, Guerini, V, Bernardini, B, Corsini, C, Boffelli, S, Filippi, A, Delpin, K, Faraci, B, Bertoletti, E, Vannucci, M, Crippa, P, Malighetti, A, Caltagirone, C, Disant, S, Bettini, D, Maltese, F, Abruzzese, G, Cosimo, D, Azzini, M, Colombo, M, Procino, G, Fascendini, S, Barocco, F, Del, P, Mazzone, A, Cottino, M, Vezzadini, G, Avanzi, S, Brambilla, C, Orini, S, Sgrilli, F, Mello, A, Lombardi Muti, L E, Dijk, B, Fenu, S, Pes, C, Gareri, P, Passamonte, M, Rigo, R, Locusta, L, Caser, L, Rosso, G, Cesarini, S, Cozzi, R, Santini, C, Carbone, P, Cazzaniga, I, Lovati, R, Cantoni, A, Ranzani, P, Barra, D, Pompilio, G, Dimori, S, Cernesi, S, Riccò, C, Piazzolla, F, Capittini, E, Rota, C, Gottardi, F, Merla, L, Barelli, A, Millul, A, De, G, Morrone, G, Bigolari, M, Macchi, M, Zambon, F, Pizzorni, C, Dicasaleto, G, Menculini, G, Marcacci, M, Catanese, G, Sprini, D, Dicasalet, T, Bocci, M, Borga, S, Caironi, P, Cat, C, Cingolani, E, Avalli, L, Greco, G, Citerio, G, Gandini, L, Cornara, G, Lerda, R, Brazzi, L, Simeone, F, Caciorgna, M, Alampi, D, Francesconi, S, Beck, E, Antonini, B, Vettoretto, K, Meggiolaro, M, Garofalo, E, Notaro, S, Varutti, R, Bassi, F, Mistraletti, G, Marino, A, Rona, R, Rondelli, E, Riva, I, Cortegiani, A, Pistidda, L, D’Andrea, R, Querci, L, Gnesin, P, Todeschini, M, Lugano, M, Castelli, G, Ortolani, M, Cotoia, A, Maggiore, S, Ditizio, L, Graziani, R, Testa, I, Ferretti, E, Castioni, C, Lombardi, F, Caserta, R, Pasqua, M, Simoncini, S, Baccarini, F, Rispoli, M, Grossi, F, Cancelliere, L, Carnelli, M, Puccini, F, Biancofiore, G, Siniscalchi, A, Laici, C, Mossello, E, Torrini, M, Pasetti, G, Palmese, S, Oggioni, R, Mangani, V, Pini, S, Martelli, M, Rigo, E, Zuccalà, F, Cherri, A, Spina, R, Calamai, I, Petrucci, N, Caicedo, A, Ferri, F, Gritti, P, Brienza, N, Fonnesu, R, Dessena, M, Fullin, G, Saggioro, D, Sidoli, Chiara, Zambon, Antonella, Tassistro, Elena, Rossi, Emanuela, Mossello, Enrico, Inzitari, Marco, Cherubini, Antonio, Marengoni, Alessandra, Morandi, Alessandro, Bellelli, Giuseppe, A Tarasconi, M Sella, G Paternò, G Faggian, C Lucarelli, N De Grazia, C Alberto, L Porcella, I Nardiello, E Chimenti, M Zeni, E Romairone, C Minaglia, C Ceccotti, G Guerra, G Mantovani, F Monacelli, C Minaglia, T Candiani, F Santolini, C Minaglia, M Rosso, V Bono, S Sibilla, P Dal Santo, M Ceci, P Barone, T Schirinzi, A Formenti, G Nastasi, G Isaia, D Gonella, A Battuello, S Casson, D Calvani, F Boni, A Ciaccio, R Rosa, G Sanna, S Manfredini, L Cortese, M Rizzo, R Prestano, A Greco, M Lauriola, G Gelosa, V Piras, M Arena, D Cosenza, A Bellomo, M LaMontagna, L Gabbani, L Lambertucci, S Perego, G Parati, G Basile, V Gallina, G Pilone, C Giudice, L Pietrogrande, M Mosca, I Corazzin, P Rossi, V Nunziata, F D’Amico, A Grippa, S Giardini, R 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Alessandro, P Calogero, G Corvalli, F Di, D Pezzoni, C Platto, V D’Ambrosio, C Ivaldi, P Milia, F DeSalvo, C Solaro, M Strazzacappa, M Bo, A Panico, M Cazzadori, M Bonetto, M Grasso, E Troisi, G Magnani, G Cecchetti, V Guerini, B Bernardini, C Corsini, S Boffelli, A Filippi, K Delpin, B Faraci, E Bertoletti, M Vannucci, P Crippa, A Malighetti, C Caltagirone, S DiSant, D Bettini, F Maltese, M Formilan, G Abruzzese, C Minaglia, D Cosimo, M Azzini, M Cazzadori, M Colombo, G Procino, S Fascendini, F Barocco, P Del, F D’Amico, A Grippa , A Mazzone, M Cottino, G Vezzadini, S Avanzi, C Brambilla, S Orini, F Sgrilli, A Mello, L E Lombardi Muti, B Dijk , S Fenu, C Pes, P Gareri, A Castagna, M Passamonte, R Rigo, L Locusta, L Caser, G Rosso, S Cesarini, R Cozzi, C Santini, P Carbone, I Cazzaniga, R Lovati, A Cantoni, P Ranzani, D Barra, G Pompilio, S Dimori, S Cernesi, C Riccò, F Piazzolla, E Capittini, C Rota, F Gottardi, L Merla, A Barelli, A Millul , G De, G Morrone, M Bigolari, C Minaglia, M Macchi, F Zambon, F D’Amico, F D’Amico, C Pizzorni, G DiCasaleto, G Menculini, M Marcacci, G Catanese, D Sprini, T DiCasalet, M Bocci, S Borga, P Caironi, C Cat, E Cingolani, L Avalli, G Greco, G Citerio, L Gandini, G Cornara, R Lerda, L Brazzi, F Simeone, M Caciorgna, D Alampi, S Francesconi, E Beck, B Antonini, K Vettoretto, M Meggiolaro, E Garofalo, A Bruni, S Notaro, R Varutti, F Bassi, G Mistraletti, A Marino, R Rona, E Rondelli, I Riva, A Cortegiani, L Pistidda, R D’Andrea, L Querci, P Gnesin, M Todeschini, M Lugano, G Castelli, M Ortolani, A Cotoia, S Maggiore, L DiTizio, R Graziani, I Testa, E Ferretti, C Castioni, F Lombardi, R Caserta, M Pasqua, S Simoncini, F Baccarini, M Rispoli, F Grossi, L Cancelliere, M Carnelli, F Puccini, G Biancofiore, A Siniscalchi, C Laici, E Mossello, M Torrini, G Pasetti, S Palmese, R Oggioni, V Mangani, S Pini, M Martelli, E Rigo, F Zuccalà , A Cherri, R Spina, I Calamai, N Petrucci, A Caicedo, F Ferri, P Gritti, N Brienza, R Fonnesu, M Dessena, G Fullin & D Saggioro, VU University medical center, Sidoli, C, Zambon, A, Tassistro, E, Rossi, E, Mossello, E, Inzitari, M, Cherubini, A, Marengoni, A, Morandi, A, Bellelli, G, Tarasconi, A, Sella, M, Paterno, G, Faggian, G, Lucarelli, C, De Grazia, N, Alberto, C, Porcella, L, Nardiello, I, Chimenti, E, Zeni, M, Romairone, E, Minaglia, C, Ceccotti, C, Guerra, G, Mantovani, G, Monacelli, F, Candiani, T, Santolini, F, Rosso, M, Bono, V, Sibilla, S, Dal Santo, P, Ceci, M, Barone, P, Schirinzi, T, Formenti, A, Nastasi, G, Isaia, G, Gonella, D, Battuello, A, Casson, S, Calvani, D, Boni, F, Ciaccio, A, Rosa, R, Sanna, G, Manfredini, S, Cortese, L, Rizzo, M, Prestano, R, Greco, A, Lauriola, M, Gelosa, G, Piras, V, Arena, M, Cosenza, D, Bellomo, A, Lamontagna, M, Gabbani, L, Lambertucci, L, Perego, S, Parati, G, Basile, G, Gallina, V, Pilone, G, Giudice, C, Pietrogrande, L, Mosca, M, Corazzin, I, Rossi, P, Nunziata, V, D'Amico, F, Grippa, A, Giardini, S, Barucci, R, Cossu, A, Fiorin, L, Distefano, M, Lunardelli, M, Brunori, M, Ruffini, I, Abraham, E, Varutti, A, Fabbro, E, Catalano, A, Martino, G, Leotta, D, Marchet, A, Dell'Aquila, G, Scrimieri, A, Davoli, M, Casella, M, Cartei, A, Polidori, G, Brischetto, D, Motta, S, Saponara, R, Perrone, P, Russo, G, Del, D, Car, C, Pirina, T, Franzoni, S, Cotroneo, A, Ghiggia, F, Volpi, G, Menichetti, C, Bo, M, Panico, A, Calogero, P, Corvalli, G, Mauri, M, Lupia, E, Manfredini, R, Fabbian, F, March, A, Pedrotti, M, Veronesi, M, Strocchi, E, Borghi, C, Bianchetti, A, Crucitti, A, Difrancesco, V, Fontana, G, Geriatria, A, Bonanni, L, Barbone, F, Serrati, C, Ballardini, G, Simoncelli, M, Ceschia, G, Scarpa, C, Brugiolo, R, Fusco, S, Ciarambino, T, Biagini, C, Tonon, E, Porta, M, Venuti, D, Delsette, M, Poeta, M, Barbagallo, G, Trovato, G, Delitala, A, Arosio, P, Reggiani, F, Zuliani, G, Ortolani, B, Mussio, E, Girardi, A, Coin, A, Ruotolo, G, Castagna, A, Masina, M, Cimino, R, Pinciaroli, A, Tripodi, G, Cassadonte, F, Vatrano, M, 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Saggioro, D

Subjects
Aging, Disability, Rehabilitation, Delirium, Dementia, Physical restraint, Cross-Sectional Studies, Activities of Daily Living, mental disorders, Prevalence, Humans, Geriatrics and Gerontology, Aged
Abstract

Background: Delirium is thought to be common across various settings of care; however, still little research has been conducted in rehabilitation. Aim: We investigated the prevalence of delirium, its features and motor subtypes in older patients admitted to rehabilitation facilities during the three editions of the “Delirium Day project”. Methods: We conducted a cross-sectional study in which 1237 older patients (age ≥ 65 years old) admitted to 50 Italian rehabilitation wards during the three editions of the “Delirium Day project” (2015 to 2017) were included. Delirium was evaluated through the 4AT and its motor subtype with the Delirium Motor Subtype Scale. Results: Delirium was detected in 226 patients (18%), and the most recurrent motor subtype was mixed (37%), followed by hypoactive (26%), hyperactive (21%) and non-motor one (16%). In a multivariate Poisson regression model with robust variance, factors associated with delirium were: disability in basic (PR 1.48, 95%CI: 1.17–1.9, p value 0.001) and instrumental activities of daily living (PR 1.58, 95%CI: 1.08–2.32, p value 0.018), dementia (PR 2.10, 95%CI: 1.62–2.73, p value < 0.0001), typical antipsychotics (PR 1.47, 95%CI: 1.10–1.95, p value 0.008), antidepressants other than selective serotonin reuptake inhibitors (PR 1.3, 95%CI: 1.02–1.66, p value 0.035), and physical restraints (PR 2.37, 95%CI: 1.68–3.36, p value < 0.0001). Conclusion: This multicenter study reports that 2 out 10 patients admitted to rehabilitations had delirium on the index day. Mixed delirium was the most prevalent subtype. Delirium was associated with unmodifiable (dementia, disability) and modifiable (physical restraints, medications) factors. Identification of these factors should prompt specific interventions aimed to prevent or mitigate delirium.

Published
2022
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29. The association between low skeletal muscle mass and delirium: results from the nationwide multi-centre Italian Delirium Day 2017

Author

Zucchelli, A, Manzoni, F, Morandi, A, Di Santo, S, Rossi, E, Valsecchi, Mg, Inzitari, M, Cherubini, A, Bo, M, Mossello, E, Marengoni, A, Bellelli, G, Tarasconi, A, Sella, M, Auriemma, S, Paternò, G, Faggian, G, Lucarelli, C, De Grazia, N, Alberto, C, Margola, A, Porcella, L, Nardiello, I, Chimenti, E, Zeni, M, Giani, A, Famularo, S, Romairone, E, Minaglia, C, Ceccotti, C, Guerra, G, Mantovani, G, Monacelli, F, Candiani, T, Ballestrero, A, Santolini, F, Rosso, M, Bono, V, Sibilla, S, Dal Santo, P, Ceci, M, Barone, P, Schirinzi, T, Formenti, A, Nastasi, G, Isaia, G, Gonella, D, Battuello, A, Casson, S, Calvani, D, Boni, F, Ciaccio, A, Rosa, R, Sanna, G, Manfredini, S, Cortese, L, Rizzo, M, Prestano, R, Greco, A, Lauriola, M, Gelosa, G, Piras, V, Arena, M, Cosenza, D, Bellomo, A, Lamontagna, M, Gabbani, L, Lambertucci, L, Perego, S, Parati, G, Basile, G, Gallina, V, Pilone, G, Giudice, C, De, F, Pietrogrande, L, De, B, Mosca, M, Corazzin, I, Rossi, P, Nunziata, V, D'Amico, F, Grippa, A, Giardini, S, Barucci, R, Cossu, A, Fiorin, L, Distefano, M, Lunardelli, M, Brunori, M, Ruffini, I, Abraham, E, Varutti, A, Fabbro, E, Catalano, A, Martino, G, Leotta, D, Marchet, A, Dell'Aquila, G, Scrimieri, A, Davoli, M, Casella, M, Cartei, A, Polidori, G, Brischetto, D, Motta, S, Saponara, R, Perrone, P, Russo, G, Del, D, Car, C, Pirina, T, Franzoni, S, Cotroneo, A, Ghiggia, F, Volpi, G, Menichetti, C, Panico, A, Calogero, P, Corvalli, G, Mauri, M, Lupia, E, Manfredini, R, Fabbian, F, March, A, Pedrotti, M, Veronesi, M, Strocchi, E, Bianchetti, A, Crucitti, A, Di Francesco, V, Fontana, G, Bonanni, L, Barbone, F, Serrati, C, Ballardini, G, Simoncelli, M, Ceschia, G, Scarpa, C, Brugiolo, R, Fusco, S, Ciarambino, T, Biagini, C, Tonon, E, Porta, M, Venuti, D, Delsette, M, Poeta, M, Barbagallo, G, Trovato, G, Delitala, A, Arosio, P, Reggiani, F, Zuliani, G, Ortolani, B, Mussio, E, Girardi, A, Coin, A, Ruotolo, G, Castagna, A, Masina, M, Cimino, R, Pinciaroli, A, Tripodi, G, Cannistrà, U, 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S, Scarpa, A, Zara, D, Ranieri, P, Pezzoni, D, Gentile, S, Platto, C, D'Ambrosio, V, Faraci, B, Brambilla, C, Ivaldi, C, Milia, P, Desalvo, F, Solaro, C, Strazzacappa, M, Cazzadori, M, Confente, S, Grasso, M, Troisi, E, Guerini, V, Bernardini, B, C Boffelli S, Corsini, Filippi, A, Delpin, K, Bertoletti, E, Vannucci, M, Tesi, F, Crippa, P, Malighetti, A, Caltagirone, C, Disant, S, Bettini, D, Maltese, F, Abruzzese, G, Cosimo, D, Azzini, M, Colombo, M, Procino, G, Fascendini, S, Barocco, F, Del, P, Mazzone, A, Riva, E, Dell'Acqua, D, Cottino, M, Vezzadini, G, Avanzi, S, Orini, S, Sgrilli, F, Mello, A, Lombardi, L, Muti, E, Dijk, B, Fenu, S, Pes, C, Gareri, P, Passamonte, M, Rigo, R, Locusta, L, Caser, L, Rosso, G, Cesarini, S, Cozzi, R, Santini, C, Carbone, P, Cazzaniga, I, Lovati, R, Cantoni, A, Ranzani, P, Barra, D, Pompilio, G, Dimori, S, Cernesi, S, Riccò, C, Piazzolla, F, Capittini, E, Rota, C, Gottardi, F, Merla, L, A Millul A, Barelli, De, G, Morrone, G, Bigolari, M, Macchi, M, 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A, Ferri, F, Gritti, P, Brienza, N, Fonnesu, R, Dessena, M, Fullin, G, Saggioro, D., Zucchelli, A, Manzoni, F, Morandi, A, Di Santo, S, Rossi, E, Valsecchi, M, Inzitari, M, Cherubini, A, Bo, M, Mossello, E, Marengoni, A, Bellelli, G, Citerio, G, Zucchelli, Alberto, Valsecchi, M G, and A Tarasconi, M Sella, S Auriemma, G Paternò, G Faggian, C Lucarelli, N De Grazia, C Alberto, A Margola, L Porcella, I Nardiello, E Chimenti, M Zeni, A Giani, S Famularo, E Romairone, C Minaglia, C Ceccotti, G Guerra, G Mantovani, F Monacelli, C Minaglia, T Candiani, A Ballestrero, C Minaglia, F Santolini, C Minaglia, M Rosso, V Bono, S Sibilla, P Dal Santo, M Ceci, P Barone, T Schirinzi, A Formenti, G Nastasi, G Isaia, D Gonella, A Battuello, S Casson, D Calvani, F Boni, A Ciaccio, R Rosa, G Sanna, S Manfredini, L Cortese, M Rizzo, R Prestano, A Greco, M Lauriola, G Gelosa, V Piras, M Arena, D Cosenza, A Bellomo, M LaMontagna, L Gabbani, L Lambertucci, S Perego, G Parati, G Basile, V Gallina, G Pilone, C Giudice, F De, L Pietrogrande, B De, M Mosca, I Corazzin, P Rossi, V Nunziata, F D'Amico, A Grippa, S Giardini, R Barucci, A Cossu, L Fiorin, M Arena, M Distefano, M Lunardelli, M Brunori, I Ruffini, E Abraham, A Varutti, E Fabbro, A Catalano, G Martino, D Leotta, A Marchet, G Dell'Aquila, A Scrimieri, M Davoli, M Casella, A Cartei, G Polidori, G Basile, D Brischetto, S Motta, R Saponara, P Perrone, G Russo, D Del, C Car, T Pirina, S Franzoni, A Cotroneo, F Ghiggia, G Volpi, C Menichetti, M Bo, A Panico, P Calogero, G Corvalli, M Mauri, E Lupia, R Manfredini, F Fabbian, A March, M Pedrotti, M Veronesi, E Strocchi, A Bianchetti, A Crucitti, V Di Francesco, G Fontana, L Bonanni, F Barbone, C Serrati, G Ballardini, M Simoncelli, G Ceschia, C Scarpa, R Brugiolo, S Fusco, T Ciarambino, C Biagini, E Tonon, M Porta, D Venuti, M DelSette, M Poeta, G Barbagallo, G Trovato, A Delitala, P Arosio, F Reggiani, G Zuliani, B Ortolani, E Mussio, A Girardi, A Coin, G Ruotolo, A Castagna, M Masina, R Cimino, A Pinciaroli, G Tripodi, U Cannistrà, F Cassadonte, M Vatrano, F Cassandonte, L Scaglione, P Fogliacco, C Muzzuilini, F Romano, A Padovani, L Rozzini, A Cagnin, F Fragiacomo, G Desideri, E Liberatore, A Bruni, G Orsitto, M Franco, L Bonfrate, M Bonetto, N Pizio, G Magnani, G Cecchetti, A Longo, V Bubba, L Marinan, M Cotelli, M Turla, M Brunori, M Sessa, L Abruzzi, G Castoldi, D LoVetere, C Musacchio, M Novello, A Cavarape, A Bini, A Leonardi, F Seneci, W Grimaldi, F Fimognari, V Bambara, A Saitta, F Corica, M Braga, E Ettorre, C Camellini, A Marengoni, A Bruni, A Crescenzo, G Noro, R Turco, M Ponzetto, L Giuseppe, B Mazzei, G Maiuri, D Costaggiu, R Damato, E Fabbro, G Patrizia, L Santuari, M Gallucci, C Minaglia, M Paragona, P Bini, D Modica, C Abati, M Clerici, I Barbera, F NigroImperiale, A Manni, C Votino, C Castiglioni, M Di, M Degl'Innocenti, G Moscatelli, S Guerini, C Casini, D Dini, S DeNotariis, F Bonometti, C Paolillo, A Riccardi, A Tiozzo, A SamySalamaFahmy, A Riccardi, C Paolillo, M DiBari, S Vanni, A Scarpa, D Zara, P Ranieri, P Calogero, G Corvalli, D Pezzoni, S Gentile, A Morandi, C Platto, V D'Ambrosio, B Faraci, C Ivaldi, P Milia, F DeSalvo, C Solaro, M Strazzacappa, M Bo, A Panico, M Cazzadori, S Confente, M Bonetto, G Magnani, G Cecchetti, V Guerini, B Bernardini, C Corsini, S Boffelli, A Filippi, K Delpin, E Bertoletti, M Vannucci, F Tesi, P Crippa, A Malighetti, C Caltagirone, S DiSant, D Bettini, F Maltese, M Formilan, G Abruzzese, C Minaglia, D Cosimo, M Azzini, M Cazzadori, M Colombo, G Procino, S Fascendini, F Barocco, P Del, F D'Amico, A Grippa, A Mazzone, E Riva, D Dell'Acqua, M Cottino, G Vezzadini, S Avanzi, S Orini, F Sgrilli, A Mello, L Lombardi, E Muti, B Dijk, S Fenu, C Pes, P Gareri, A Castagna, M Passamonte, F De, R Rigo, L Locusta, L Caser, G Rosso, S Cesarini, R Cozzi, C Santini, P Carbone, I Cazzaniga, R Lovati, A Cantoni, P Ranzani, D Barra, G Pompilio, S Dimori, S Cernesi, C Riccò, F Piazzolla, E Capittini, C Rota, F Gottardi, L Merla, A Barelli, A Millul, G De, G Morrone, M Bigolari, C Minaglia, M Macchi, F Zambon, F D'Amico, F D'Amico, C Pizzorni, G DiCasaleto, G Menculini, M Marcacci, G Catanese, D Sprini, T DiCasalet, M Bocci, S Borga, P Caironi, C Cat, E Cingolani, L Avalli, G Greco, G Citerio, L Gandini, G Cornara, R Lerda, L Brazzi, F Simeone, M Caciorgna, D Alampi, S Francesconi, E Beck, B Antonini, K Vettoretto, M Meggiolaro, E Garofalo, A Bruni, S Notaro, R Varutti, F Bassi, G Mistraletti, A Marino, R Rona, E Rondelli, I Riva, A Scapigliati, A Cortegiani, F Vitale, L Pistidda, R D'Andrea, L Querci, P Gnesin, M Todeschini, M Lugano, G Castelli, M Ortolani, A Cotoia, S Maggiore, L DiTizio, R Graziani, I Testa, E Ferretti, C Castioni, F Lombardi, R Caserta, M Pasqua, S Simoncini, F Baccarini, M Rispoli, F Grossi, L Cancelliere, M Carnelli, F Puccini, G Biancofiore, A Siniscalchi, C Laici, E Mossello, M Torrini, G Pasetti, S Palmese, R Oggioni, V Mangani, S Pini, M Martelli, E Rigo, F Zuccalà, A Cherri, R Spina, I Calamai, N Petrucci, A Caicedo, F Ferri, P Gritti, N Brienza, R Fonnesu, M Dessena, G Fullin, D Saggioro

Subjects
Male, Aging, medicine.medical_specialty, Sarcopenia, medicine.medical_treatment, Socio-culturale, Older person, Logistic regression, Delirium, Older persons, Sarcopenia, Internal medicine, mental disorders, Delirium, Older persons, medicine, Dementia, Humans, LS4_4, Muscle, Skeletal, Pathological, Aged, Rehabilitation, business.industry, Area under the curve, Settore MED/23 - Chirurgia Cardiaca, Skeletal, medicine.disease, Skeletal muscle mass, Cross-Sectional Studies, Italy, Muscle, Female, Geriatrics and Gerontology, medicine.symptom, business
Abstract

Introduction Delirium and sarcopenia are common, although underdiagnosed, geriatric syndromes. Several pathological mechanisms can link delirium and low skeletal muscle mass, but few studies have investigated their association. We aimed to investigate (1) the association between delirium and low skeletal muscle mass and (2) the possible role of calf circumference mass in finding cases with delirium. Methods The analyses were conducted employing the cross-sectional “Delirium Day” initiative, on patient 65 years and older admitted to acute hospital medical wards, emergency departments, rehabilitation wards, nursing homes and hospices in Italy in 2017. Delirium was diagnosed as a 4 + score at the 4-AT scale. Low skeletal muscle mass was operationally defined as calf circumference ≤ 34 cm in males and ≤ 33 cm in females. Logistic regression models were used to investigate the association between low skeletal muscle mass and delirium. The discriminative ability of calf circumference was evaluated using non-parametric ROC analyses. Results A sample of 1675 patients was analyzed. In total, 73.6% of participants had low skeletal muscle mass and 24.1% exhibited delirium. Low skeletal muscle mass and delirium showed an independent association (OR: 1.50; 95% CI 1.09–2.08). In the subsample of patients without a diagnosis of dementia, the inclusion of calf circumference in a model based on age and sex significantly improved its discriminative accuracy [area under the curve (AUC) 0.69 vs 0.57, p Discussion and conclusion Low muscle mass is independently associated with delirium. In patients without a previous diagnosis of dementia, calf circumference may help to better identify those who develop delirium.

Published
2022

30. Visual and Hearing Impairment Are Associated With Delirium in Hospitalized Patients: Results of a Multisite Prevalence Study

Author

Alessandro Morandi, Marco Inzitari, Cristina Udina, Neus Gual, Miriam Mota, Elena Tassistro, Anita Andreano, Antonio Cherubini, Simona Gentile, Enrico Mossello, Alessandra Marengoni, Anna Olivé, Francesc Riba, Domingo Ruiz, Elisabet de Jaime, Giuseppe Bellelli, A. Tarasconi, M. Sella, S. Auriemma, G. Paternò, G. Faggian, C. Lucarelli, N. De Grazia, C. Alberto, A. Margola, L. Porcella, I. Nardiello, E. Chimenti, M. Zeni, A. Giani, S. Famularo, E. Romairone, C. Minaglia, C. Ceccotti, G. Guerra, G. Mantovani, F. Monacelli, T. Candiani, A. Ballestrero, F. Santolini, M. Rosso, V. Bono, S. Sibilla, P. Dal Santo, M. Ceci, P. Barone, T. Schirinzi, A. Formenti, G. Nastasi, G. Isaia, D. Gonella, A. Battuello, S. Casson, D. Calvani, F. Boni, A. Ciaccio, R. Rosa, G. Sanna, S. Manfredini, L. Cortese, M. Rizzo, R. Prestano, A. Greco, M. Lauriola, G. Gelosa, V. Piras, M. Arena, D. Cosenza, A. Bellomo, M. LaMontagna, L. Gabbani, L. Lambertucci, S. Perego, G. Parati, G. Basile, V. Gallina, G. Pilone, C. Giudice, F. De, L. Pietrogrande, B. De, M. Mosca, I. Corazzin, P. Rossi, V. Nunziata, F. D'Amico, A. Grippa, S. Giardini, R. Barucci, A. Cossu, L. Fiorin, M. Distefano, M. Lunardelli, M. Brunori, I. Ruffini, E. Abraham, A. Varutti, E. Fabbro, A. Catalano, G. Martino, D. Leotta, A. Marchet, G. Dell'Aquila, A. Scrimieri, M. Davoli, M. Casella, A. Cartei, G. Polidori, D. Brischetto, S. Motta, R. Saponara, P. Perrone, G. Russo, D. Del, C. Car, T. Pirina, S. Franzoni, A. Cotroneo, F. Ghiggia, G. Volpi, C. Menichetti, M. Bo, A. Panico, P. Calogero, G. Corvalli, M. Mauri, E. Lupia, R. Manfredini, F. Fabbian, A. March, M. Pedrotti, M. Veronesi, E. Strocchi, C. Borghi, A. Bianchetti, A. Crucitti, V. DiFrancesco, G. Fontana, L. Bonanni, F. Barbone, C. Serrati, G. Ballardini, M. Simoncelli, G. Ceschia, C. Scarpa, R. Brugiolo, S. Fusco, T. Ciarambino, C. Biagini, E. Tonon, M. Porta, D. Venuti, M. DelSette, M. Poeta, G. Barbagallo, G. Trovato, A. Delitala, P. Arosio, F. Reggiani, G. Zuliani, B. Ortolani, E. Mussio, A. Girardi, A. Coin, G. Ruotolo, A. Castagna, M. Masina, R. Cimino, A. Pinciaroli, G. Tripodi, U. Cannistrà, F. Cassadonte, M. Vatrano, L. Scaglione, P. Fogliacco, C. Muzzuilini, F. Romano, A. Padovani, L. Rozzini, A. Cagnin, F. Fragiacomo, G. Desideri, E. Liberatore, A. Bruni, G. Orsitto, M. Franco, L. Bonfrate, M. Bonetto, N. Pizio, G. Magnani, G. Cecchetti, A. Longo, V. Bubba, L. Marinan, M. Cotelli, M. Turla, M. Sessa, L. Abruzzi, G. Castoldi, D. LoVetere, C. Musacchio, M. Novello, A. Cavarape, A. Bini, A. Leonardi, F. Seneci, W. Grimaldi, F. Fimognari, V. Bambara, A. Saitta, F. Corica, M. Braga, E. Ettorre, C. Camellini, G. Bellelli, G. Annoni, A. Marengoni, A. Crescenzo, G. Noro, R. Turco, M. Ponzetto, L. Giuseppe, B. Mazzei, G. Maiuri, D. Costaggiu, R. Damato, M. Formilan, G. Patrizia, M. Gallucci, M. Paragona, P. Bini, D. Modica, C. Abati, M. Clerici, I. Barbera, F. NigroImperiale, A. Manni, C. Votino, C. Castiglioni, M. Di, M. Degl'Innocenti, G. Moscatelli, S. Guerini, C. Casini, D. Dini, E. D'Imporzano, S. DeNotariis, F. Bonometti, C. Paolillo, A. Riccardi, A. Tiozzo, M. DiBari, S. Vanni, A. Scarpa, D. Zara, P. Ranieri, M. Alessandro, F. Di, D. Pezzoni, C. Platto, V. D'Ambrosio, C. Ivaldi, P. Milia, F. DeSalvo, C. Solaro, M. Strazzacappa, M. Cazzadori, S. Confente, M. Grasso, E. Troisi, V. Guerini, B. Bernardini, C. Corsini, S. Boffelli, A. Filippi, K. Delpin, B. Faraci, E. Bertoletti, M. Vannucci, F. Tesi, P. Crippa, A. Malighetti, D. Bettini, F. Maltese, G. Abruzzese, D. Cosimo, M. Azzini, M. Colombo, G. Procino, S. Fascendini, F. Barocco, P. Del, A. Mazzone, E. Riva, D. Dell'Acqua, M. Cottino, G. Vezzadini, S. Avanzi, C. Brambilla, S. Orini, F. Sgrilli, A. Mello, L. Lombardi, E. Muti, B. Dijk, S. Fenu, C. Pes, P. Gareri, M. Passamonte, R. Rigo, L. Locusta, L. Caser, G. Rosso, S. Cesarini, R. Cozzi, C. Santini, P. Carbone, I. Cazzaniga, R. Lovati, A. Cantoni, P. Ranzani, D. Barra, G. Pompilio, S. Dimori, S. Cernesi, C. Riccò, F. Piazzolla, E. Capittini, C. Rota, F. Gottardi, L. Merla, A. Barelli, A. Millul, G. De, G. Morrone, M. Bigolari, M. Macchi, F. Zambon, C. Pizzorni, G. DiCasaleto, G. Menculini, M. Marcacci, G. Catanese, D. Sprini, T. DiCasalet, M. Bocci, S. Borga, P. Caironi, C. Cat, E. Cingolani, L. Avalli, G. Greco, G. Citerio, L. Gandini, G. Cornara, R. Lerda, L. Brazzi, F. Simeone, M. Caciorgna, D. Alampi, S. Francesconi, E. Beck, B. Antonini, K. Vettoretto, M. Meggiolaro, E. Garofalo, S. Notaro, R. Varutti, F. Bassi, G. Mistraletti, A. Marino, R. Rona, E. Rondelli, I. Riva, A. Scapigliati, A. Cortegiani, F. Vitale, L. Pistidda, R. D'Andrea, L. Querci, P. Gnesin, M. Todeschini, M. Lugano, G. Castelli, M. Ortolani, A. Cotoia, S. Maggiore, L. DiTizio, R. Graziani, I. Testa, E. Ferretti, C. Castioni, F. Lombardi, R. Caserta, M. Pasqua, S. Simoncini, F. Baccarini, M. Rispoli, F. Grossi, L. Cancelliere, M. Carnelli, F. Puccini, G. Biancofiore, A. Siniscalchi, C. Laici, E. Mossello, M. Torrini, G. Pasetti, S. Palmese, R. Oggioni, V. Mangani, S. Pini, M. Martelli, E. Rigo, F. Zuccalà, A. Cherri, R. Spina, I. Calamai, N. Petrucci, A. Caicedo, F. Ferri, P. Gritti, N. Brienza, R. Fonnesu, M. Dessena, G. Fullin, D. Saggioro, Morandi, A, Inzitari, M, Udina, C, Gual, N, Mota, M, Tassistro, E, Andreano, A, Cherubini, A, Gentile, S, Mossello, E, Marengoni, A, Olivé, A, Riba, F, Ruiz, D, de Jaime, E, Bellelli, G, Alessandro Morandi, Marco Inzitari, Cristina Udina, Neus Gual, Miriam Mota, Elena Tassistro, Anita Andreano, Antonio Cherubini, Simona Gentile, Enrico Mossello, Alessandra Marengoni, Anna Olivé, Francesc Riba, Domingo Ruiz, Elisabet de Jaime, Giuseppe Bellelli, Italian Study Group of Delirium, Claudio Borghi, Morandi, Alessandro, Inzitari, Marco, Udina, Cristina, Gual, Neu, Mota, Miriam, Tassistro, Elena, Andreano, Anita, Cherubini, Antonio, Gentile, Simona, Mossello, Enrico, Marengoni, Alessandra, Olivé, Anna, Riba, Francesc, Ruiz, Domingo, de Jaime, Elisabet, Bellelli, Giuseppe, and A Tarasconi, M Sella, S Auriemma, G Paternò, G Faggian, C Lucarelli, N De Grazia, C Alberto, A Margola, L Porcella, I Nardiello, E Chimenti, M Zeni, A Giani, S Famularo, E Romairone, C Minaglia, C Ceccotti, G Guerra, G Mantovani, F Monacelli, C Minaglia, T Candiani, A Ballestrero, C Minaglia, F Santolini, C Minaglia, M Rosso, V Bono, S Sibilla, P Dal Santo, M Ceci, P Barone, T Schirinzi, A Formenti, G Nastasi, G Isaia, D Gonella, A Battuello, S Casson, D Calvani, F Boni, A Ciaccio, R Rosa, G Sanna, S Manfredini, L Cortese, M Rizzo, R Prestano, A Greco, M Lauriola, G Gelosa, V Piras, M Arena, D Cosenza, A Bellomo, M LaMontagna, L Gabbani, L Lambertucci, S Perego, G Parati, G Basile, V Gallina, G Pilone, C Giudice, F De, L Pietrogrande, B De, M Mosca, I Corazzin, P Rossi, V Nunziata, F D'Amico, A Grippa, S Giardini, R Barucci, A Cossu, L Fiorin, M Arena, M Distefano, M Lunardelli, M Brunori, I Ruffini, E Abraham, A Varutti, E Fabbro, A Catalano, G Martino, D Leotta, A Marchet, G Dell'Aquila, A Scrimieri, M Davoli, M Casella, A Cartei, G Polidori, G Basile, D Brischetto, S Motta, R Saponara, P Perrone, G Russo, D Del, C Car, T Pirina, S Franzoni, A Cotroneo, F Ghiggia, G Volpi, C Menichetti, M Bo, A Panico, P Calogero, G Corvalli, M Mauri, E Lupia, R Manfredini, F Fabbian, A March, M Pedrotti, M Veronesi, E Strocchi, C Borghi, A Bianchetti, A Crucitti, V DiFrancesco, G Fontana, L Bonanni, F Barbone, C Serrati, G Ballardini, M Simoncelli, G Ceschia, C Scarpa, R Brugiolo, S Fusco, T Ciarambino, C Biagini, E Tonon, M Porta, D Venuti, M DelSette, M Poeta, G Barbagallo, G Trovato, A Delitala, P Arosio, F Reggiani, G Zuliani, B Ortolani, E Mussio, A Girardi, A Coin, G Ruotolo, A Castagna, M Masina, R Cimino, A Pinciaroli, G Tripodi, U Cannistrà, F Cassadonte, M Vatrano, L Scaglione, P Fogliacco, C Muzzuilini, F Romano, A Padovani, L Rozzini, A Cagnin, F Fragiacomo, G Desideri, E Liberatore, A Bruni, G Orsitto, M Franco, L Bonfrate, M Bonetto, N Pizio, G Magnani, G Cecchetti, A Longo, V Bubba, L Marinan, M Cotelli, M Turla, M Brunori, M Sessa, L Abruzzi, G Castoldi, D LoVetere, C Musacchio, M Novello, A Cavarape, A Bini, A Leonardi, F Seneci, W Grimaldi, F Seneci, F Fimognari, V Bambara, A Saitta, F Corica, M Braga, E Ettorre, C Camellini, G Bellelli, G Annoni, A Marengoni, A Bruni, A Crescenzo, G Noro, R Turco, M Ponzetto, L Giuseppe, B Mazzei, G Maiuri, D Costaggiu, R Damato, E Fabbro, M Formilan, G Patrizia, M Gallucci, C Minaglia, M Paragona, P Bini, D Modica, C Abati, M Clerici, I Barbera, F NigroImperiale, A Manni, C Votino, C Castiglioni, M Di, M Degl'Innocenti, G Moscatelli, S Guerini, C Casini, D Dini, E D'Imporzano, S DeNotariis, F Bonometti, C Paolillo, A Riccardi, A Tiozzo, A Riccardi, C Paolillo, M DiBari, S Vanni, A Scarpa, D Zara, P Ranieri, M Alessandro, P Calogero, G Corvalli, F Di, D Pezzoni, C Platto, V D'Ambrosio, C Ivaldi, P Milia, F DeSalvo, C Solaro, M Strazzacappa, M Bo, A Panico, M Cazzadori, S Confente, M Bonetto, M Grasso, E Troisi, G Magnani, G Cecchetti, V Guerini, B Bernardini, C Corsini, S Boffelli, A Filippi, K Delpin, B Faraci, E Bertoletti, M Vannucci, F Tesi, P Crippa, A Malighetti, D Bettini, F Maltese, M Formilan, G Abruzzese, C Minaglia, D Cosimo, M Azzini, M Cazzadori, M Colombo, G Procino, S Fascendini, F Barocco, P Del, F D'Amico, A Grippa, A Mazzone, E Riva, D Dell'Acqua, M Cottino, G Vezzadini, S Avanzi, C Brambilla, S Orini, F Sgrilli, A Mello, L Lombardi, E Muti, B Dijk, S Fenu, C Pes, P Gareri, A Castagna, M Passamonte, F De, R Rigo, L Locusta, L Caser, G Rosso, S Cesarini, R Cozzi, C Santini, P Carbone, I Cazzaniga, R Lovati, A Cantoni, P Ranzani, D Barra, G Pompilio, S Dimori, S Cernesi, C Riccò, F Piazzolla, E Capittini, C Rota, F Gottardi, L Merla, A Barelli, A Millul, G De, G Morrone, M Bigolari, C Minaglia, M Macchi, F Zambon, F D'Amico, F D'Amico, C Pizzorni, G DiCasaleto, G Menculini, M Marcacci, G Catanese, D Sprini, T DiCasalet, M Bocci, S Borga, P Caironi, C Cat, E Cingolani, L Avalli, G Greco, G Citerio, L Gandini, G Cornara, R Lerda, L Brazzi, F Simeone, M Caciorgna, D Alampi, S Francesconi, E Beck, B Antonini, K Vettoretto, M Meggiolaro, E Garofalo, A Bruni, S Notaro, R Varutti, F Bassi, G Mistraletti, A Marino, R Rona, E Rondelli, I Riva, A Scapigliati, A Cortegiani, F Vitale, L Pistidda, R D'Andrea, L Querci, P Gnesin, M Todeschini, M Lugano, G Castelli, M Ortolani, A Cotoia, S Maggiore, L DiTizio, R Graziani, I Testa, E Ferretti, C Castioni, F Lombardi, R Caserta, M Pasqua, S Simoncini, F Baccarini, M Rispoli, F Grossi, L Cancelliere, M Carnelli, F Puccini, G Biancofiore, A Siniscalchi, C Laici, E Mossello, M Torrini, G Pasetti, S Palmese, R Oggioni, V Mangani, S Pini, M Martelli, E Rigo, F Zuccalà, A Cherri, R Spina, I Calamai, N Petrucci, A Caicedo, F Ferri, P Gritti, N Brienza, R Fonnesu, M Dessena, G Fullin, D Saggioro

Subjects
medicine.medical_specialty, Activities of daily living, Cross-sectional study, Hearing loss, medicine.medical_treatment, Visual impairment, Psychological intervention, visual impairment, Socio-culturale, behavioral disciplines and activities, Hearing impairment, delirium, older, sensory deficits, visual impairment, sensory deficit, Hearing impairment, 03 medical and health sciences, delirium, older, sensory deficits, 0302 clinical medicine, Risk Factors, Activities of Daily Living, mental disorders, medicine, Humans, Dementia, 030212 general & internal medicine, LS4_4, Hearing Loss, General Nursing, Rehabilitation, business.industry, Health Policy, General Medicine, medicine.disease, nervous system diseases, Cross-Sectional Studies, Italy, Emergency medicine, Delirium, Geriatrics and Gerontology, medicine.symptom, business, 030217 neurology & neurosurgery
Abstract

Objective: Sensory deficits are important risk factors for delirium but have been investigated in single-center studies and single clinical settings. This multicenter study aims to evaluate the association between hearing and visual impairment or bi-sensory impairment (visual and hearing impairment) and delirium. Design: Cross-sectional study nested in the 2017 "Delirium Day" project. Setting and participants: Patients 65 years and older admitted to acute hospital medical wards, emergency departments, rehabilitation wards, nursing homes, and hospices in Italy. Methods: Delirium was assessed with the 4AT (a short tool for delirium assessment) and sensory deficits with a clinical evaluation. We assessed the association between delirium, hearing and visual impairment in multivariable logistic regression models, adjusting for: Model 1, we included predisposing factors for delirium (ie, dementia, weight loss and autonomy in the activities of daily living); Model 2, we added to Model 1 variables, which could be considered precipitating factors for delirium (ie, psychoactive drugs and urinary catheters). Results: A total of 3038 patients were included; delirium prevalence was 25%. Patients with delirium had a higher prevalence of hearing impairment (30.5% vs 18%; P < .001), visual impairment (24.2% vs 15.7%; P < .01) and bi-sensory impairment (16.2% vs 7.5%) compared with those without delirium. In the multivariable logistic regression analysis, the presence of bi-sensory impairment was associated with delirium in Model 1 [odds ratio (OR) 1.5, confidence interval (CI) 1.2-2.1; P = .00] and in Model 2 (OR 1.4; CI 1.1-1.9; P = .02), whereas the presence of visual and hearing impairment alone was not associated with delirium either in Model 1 (OR 0.8; CI 0.6-1.2, P = .36; OR 1.1; CI 0.8-1.4; P = .42) or in Model 2 (OR 0.8, CI 0.6-1.2, P = .27; OR 1.1, CI 0.8-1.4, P = .63). Conclusions and implications: Our findings support the importance of routine screening and specific interventions by a multidisciplinary team to implement optimal management of sensory impairments and hence prevention and the management of the patients with delirium.

Published
2021

31. The Clock Drawing Test as a predictor of cognitive decline in non-demented stroke patients.

Author

Cova I, Mele F, Zerini F, Maggiore L, Rosa S, Cucumo V, Brambilla M, Nicotra A, Maestri G, Bertora P, Pomati S, and Pantoni L

Subjects
Humans, Mental Status and Dementia Tests, Neuropsychological Tests, Cognitive Dysfunction diagnosis, Cognitive Dysfunction epidemiology, Cognitive Dysfunction etiology, Stroke complications, Stroke diagnosis
Abstract

Background: The early detection of patients at risk of post-stroke cognitive impairment (PSCI) may help planning subacute and long-term care. We aimed to determine the predictivity of two screening cognitive tests on the occurrence of mild cognitive impairment or dementia in acute stroke patients., Methods: A cognitive assessment within a few days of ischemic or hemorrhagic stroke was performed in patients consecutively admitted to a stroke unit over 14 months by means of the Clock Drawing Test (CDT) and the Montreal Cognitive Assessment-Basic (MoCA-B)., Results: Out of 191 stroke survivors who were non-demented at baseline, 168 attended at least one follow-up visit. At follow-up (mean duration ± SD 12.8 ± 8.7 months), 28 (18.9%) incident cases of MCI and 27 (18%) cases of dementia were recorded. In comparison with patients who remained cognitively stable at follow-up, these patients were older, less educated, had more comorbidities, a higher score on the National Institutes of Health Stroke Scale (NIHSS) at admission, more severe cerebral atrophy, and lower MoCA-B and CDT scores at baseline. In multi-adjusted (for age, education, comorbidities score, NIHSS at admission and atrophy score) model, a pathological score on baseline CDT (< 6.55) was associated with a higher risk of PSCI at follow-up (HR 2.022; 95% CI 1.025-3.989, p < 0.05) with respect to non-pathological scores. A pathological baseline score on MoCA-B (< 24) did not predict increased risk of cognitive decline at follow-up nor increased predictivity of stand-alone CDT., Conclusion: A bedside cognitive screening with the CDT helps identifying patients at higher risk of PSCI., (© 2021. The Author(s).)

Published
2022
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32. Preclinical development of a bispecific TNFα/IL-23 neutralising domain antibody as a novel oral treatment for inflammatory bowel disease.

Author

Roberts KJ, Cubitt MF, Carlton TM, Rodrigues-Duarte L, Maggiore L, Chai R, Clare S, Harcourt K, MacDonald TT, Ray KP, Vossenkämper A, West MR, and Crowe JS

Subjects
Animals, Antibodies, Monoclonal pharmacology, Female, Humans, Mice, Mice, Inbred C57BL, Antibodies, Bispecific administration & dosage, Antibodies, Bispecific pharmacology, Antibodies, Monoclonal administration & dosage, Drug Evaluation, Preclinical methods, Inflammatory Bowel Diseases drug therapy, Interleukin-23 immunology, Tumor Necrosis Factor-alpha immunology
Abstract

Anti-TNFα and anti-IL-23 antibodies are highly effective therapies for Crohn's disease or ulcerative colitis in a proportion of patients. V56B2 is a novel bispecific domain antibody in which a llama-derived IL-23p19-specific domain antibody, humanised and engineered for intestinal protease resistance, V900, was combined with a previously-described TNFα-specific domain antibody, V565. V56B2 contains a central protease-labile linker to create a single molecule for oral administration. Incubation of V56B2 with trypsin or human faecal supernatant resulted in a complete separation of the V565 and V900 monomers without loss of neutralising potency. Following oral administration of V900 and V565 in mice, high levels of each domain antibody were detected in the faeces, demonstrating stability in the intestinal milieu. In ex vivo cultures of colonic biopsies from IBD patients, treatment with V565 or V900 inhibited tissue phosphoprotein levels and with a combination of the two, inhibition was even greater. These results support further development of V56B2 as an oral therapy for IBD with improved safety and efficacy in a greater proportion of patients as well as greater convenience for patients compared with traditional monoclonal antibody therapies., (© 2021. The Author(s).)

Published
2021
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33. The impact of lockdown during SARS-CoV-2 outbreak on behavioral and psychological symptoms of dementia.

Author

Manini A, Brambilla M, Maggiore L, Pomati S, and Pantoni L

Subjects
Aged, Aged, 80 and over, Female, Humans, Italy, Male, SARS-CoV-2, Surveys and Questionnaires, Behavioral Symptoms etiology, COVID-19 prevention & control, Dementia psychology, Quarantine psychology
Abstract

Background: During Covid-19 pandemic, the Italian government adopted restrictive limitations and declared a national lockdown on March 9, which lasted until May 4 and produced dramatic consequences on people's lives. The aim of our study was to assess the impact of prolonged lockdown on behavioral and psychological symptoms of dementia (BPSD)., Methods: Between April 30 and June 8, 2020, we interviewed with a telephone-based questionnaire the caregivers of the community-dwelling patients with dementia who had their follow-up visit scheduled from March 9 to May 15 and canceled due to lockdown. Among the information collected, patients' BPSDs were assessed by the Neuropsychiatric Inventory (NPI). Non-parametric tests to compare differences between NPI scores over time and logistic regression models to explore the impact of different factors on BPSD worsening were performed., Results: A total of 109 visits were canceled and 94/109 caregivers completed the interview. Apathy, irritability, agitation and aggression, and depression were the most common neuropsychiatric symptoms experienced by patients both at baseline and during Covid-19 pandemic. Changes in total NPI and caregiver distress scores between baseline and during lockdown, although statistically significant, were overall modest. The logistic regression model failed to determine predictors of BPSD worsening during lockdown., Conclusion: This is one of the first studies to investigate the presence of BPSD during SARS-CoV-2 outbreak and related nationwide lockdown, showing only slight, likely not clinically relevant, differences in BPSD burden, concerning mostly agitation and aggression, anxiety, apathy and indifference, and irritability.

Published
2021
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34. Neuropsychological screening in the acute phase of cerebrovascular diseases.

Author

Cova I, Mele F, Zerini F, Maggiore L, Cucumo V, Brambilla M, Rosa S, Bertora P, Salvadori E, Pomati S, and Pantoni L

Subjects
Aged, Aged, 80 and over, Cognitive Dysfunction epidemiology, Female, Humans, Incidence, Male, Middle Aged, Prevalence, Cognitive Dysfunction diagnosis, Cognitive Dysfunction etiology, Neuropsychological Tests, Stroke complications
Abstract

Introduction: Cognitive impairment is a common and disabling consequence of stroke. Its prevalence, the best way to screen for it in the acute setting, and its relation with premorbid status have not been thoroughly clarified., Materials and Methods: Ischemic and hemorrhagic stroke patients admitted to our stroke unit underwent a baseline assessment that included a clinical and neuroimaging assessment, two cognitive tests (clock-drawing test, CDT; Montreal Cognitive Assessment-Basic, MoCA-B) and measures of premorbid function (including the Clinical Dementia Rating Scale). A follow-up examination was repeated 3-4 months after the acute event., Results: Two hundred and twenty-three patients (52.5% women, mean age ± SD 75.8 years ± 12.3) were evaluated. Prestroke cognitive impairment was present in 91 patients (40.8%). At follow-up, the prevalence of cognitive impairment was 49%, while its incidence among patients who did not have any prestroke cognitive impairment was 38.8%. Of the originally admitted 223 patients (71 were lost to follow-up), only 60 (26.9%) were still cognitively intact at follow-up. On regression analysis, age and baseline CDT were associated with worsening of cognitive status at follow-up. In patients without cognitive impairment at baseline, a cutoff of 23 for MoCA-B and of 8.7 for CDT scores predicted the diagnosis of post-stroke cognitive impairment with sufficient accuracy., Discussion and Conclusion: Prestroke and post-stroke cognitive impairment affect a large proportion of patients with stroke. Our findings suggest that a neuropsychological screening during the acute phase might be predictive of the development of post-stroke cognitive impairment., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Published
2020
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35. Oral Anti-Tumour Necrosis Factor Domain Antibody V565 Provides High Intestinal Concentrations, and Reduces Markers of Inflammation in Ulcerative Colitis Patients.

Author

Nurbhai S, Roberts KJ, Carlton TM, Maggiore L, Cubitt MF, Ray KP, Reckless J, Mohammed H, Irving P, MacDonald TT, Vossenkämper A, West MR, Parkes GC, and Crowe JS

Subjects
Adult, Aged, Antibodies analysis, Antibodies metabolism, Female, Humans, Intestines chemistry, Male, Middle Aged, Recombinant Proteins therapeutic use, Tumor Necrosis Factor-alpha immunology, Antibodies therapeutic use, Colitis, Ulcerative drug therapy, Immunotherapy methods, Tumor Necrosis Factor-alpha antagonists & inhibitors
Abstract

V565 is an engineered TNFα-neutralising single domain antibody formulated into enteric coated mini-tablets to enable release in the intestine after oral administration as a possible oral treatment for inflammatory bowel disease (IBD). Following oral administration, ileal recovery of V565 was investigated in four patients with terminal ileostomy. Intestinal and systemic pharmacokinetics were measured in six patients with Crohn's disease and evidence of target engagement assessed in five patients with ulcerative colitis. Following oral administration, V565 was detected at micromolar concentrations in ileal fluid from the ileostomy patients and in stools of the Crohn's patients. In four of the five ulcerative colitis patients, biopsies taken after 7d dosing demonstrated V565 in the lamina propria with co-immunostaining on CD3 + T-lymphocytes and CD14 + macrophages. Phosphorylation of signalling proteins in biopsies taken after 7d oral dosing was decreased by approximately 50%. In conclusion, enteric coating of V565 mini-tablets provided protection in the stomach with gradual release in intestinal regions affected by IBD. Immunostaining revealed V565 tissue penetration and association with inflammatory cells, while decreased phosphoproteins after 7d oral dosing was consistent with V565-TNFα engagement and neutralising activity. Overall these results are encouraging for the clinical utility of V565 in the treatment of IBD.

Published
2019
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36. Oral delivery of the anti-tumor necrosis factor α domain antibody, V565, results in high intestinal and fecal concentrations with minimal systemic exposure in cynomolgus monkeys.

Author

Crowe JS, Roberts KJ, Carlton TM, Maggiore L, Cubitt MF, Ray KP, Donnelly MC, Wahlich JC, Humphreys JI, Robinson JR, Whale GA, and West MR

Subjects
Administration, Oral, Animals, Antibodies metabolism, Antineoplastic Agents pharmacokinetics, Chemistry, Pharmaceutical methods, Feces, Hydrogen-Ion Concentration, Ileum metabolism, Intestinal Mucosa drug effects, Intestinal Mucosa metabolism, Jejunum drug effects, Jejunum metabolism, Macaca fascicularis, Solubility, Tablets, Enteric-Coated administration & dosage, Tablets, Enteric-Coated pharmacokinetics, Antibodies administration & dosage, Antineoplastic Agents administration & dosage, Ileum drug effects, Inflammatory Bowel Diseases economics, Tumor Necrosis Factor-alpha antagonists & inhibitors
Abstract

Objective: V565 is a novel oral anti-tumor necrosis factor (TNF)-α domain antibody being developed for topical treatment of inflammatory bowel disease (IBD) patients. Protein engineering rendered the molecule resistant to intestinal proteases. Here we investigate the formulation of V565 required to provide gastro-protection and enable optimal delivery to the lower intestinal tract in monkeys., Methods: Enteric-coated V565 mini-tablets were prepared and dissolution characteristics tested in vitro. Oral dosing of monkeys with enteric-coated mini-tablets containing V565 and methylene blue dye enabled in vivo localization of mini-tablet dissolution. V565 distribution in luminal contents and feces was measured by enzyme-linked immunosorbent assay (ELISA). To mimic transit across the damaged intestinal epithelium seen in IBD patients an intravenous (i.v.) bolus of V565 was given to monkeys and pharmacokinetic parameters of V565 measured in serum and urine by ELISA., Results: Enteric-coated mini-tablets resisted dissolution in 0.1 M HCl, before dissolving in a sustained release fashion at neutral pH. In orally dosed monkeys methylene blue intestinal staining indicated the jejunum and ileum as sites for mini-tablet dissolution. Measurements of V565 in monkey feces confirmed V565 survival through the intestinal tract. Systemic exposure after oral dosing was very low consistent with limited V565 mucosal penetration in healthy monkeys. The rapid clearance of V565 after i.v. dosing was consistent with renal excretion as the primary route for elimination of any V565 reaching the circulation., Conclusions: These results suggest that mini-tablets with a 24% Eudragit enteric coating are suitable for targeted release of orally delivered V565 in the intestine for topical treatment of IBD.

Published
2019
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37. Free and cued selective reminding test predicts progression to Alzheimer's disease in people with mild cognitive impairment.

Author

Grande G, Vanacore N, Vetrano DL, Cova I, Rizzuto D, Mayer F, Maggiore L, Ghiretti R, Cucumo V, Mariani C, Cappa SF, and Pomati S

Subjects
Aged, Aged, 80 and over, Association Learning, Disease Progression, Female, Humans, Male, Neuropsychological Tests, Psychiatric Status Rating Scales, Retrospective Studies, Sensitivity and Specificity, Statistics, Nonparametric, Alzheimer Disease complications, Alzheimer Disease diagnosis, Choice Behavior physiology, Cognition Disorders etiology, Cues, Mental Recall physiology
Abstract

Introduction: To assess the diagnostic accuracy of the free and cued selective reminding test (FCSRT) for the development of Alzheimer's disease (AD) in people with mild cognitive impairment (MCI)., Methods: We enrolled 187 consecutive MCI outpatients from a memory clinic that were evaluated at baseline and every 6 to 12 months through an extensive clinical and neuropsychological protocol. For each test, measures of diagnostic accuracy were obtained. To improve the overall specificity of the neuropsychological battery, we also used the diagnostic tests in parallel combination. The association between FCSRT indexes and AD was tested through proportional hazard regression models with other dementia subtypes as competing event. Laplace regression was used to model time-to-AD diagnosis as a function of FCSRT indexes., Results: The area under the curve of the FCSRT indexes ranged from 0.69 (95% CI: 0.62-0.76) to 0.76 (95% CI: 0.70-0.82). The specificity peaked up to 100% when we combined the category fluency test with the delayed total recall index of the FCSRT. Participants who tested positive at the FCSRT, as compared with those with negative tests, presented a twofold to fivefold higher risk of developing AD (median follow-up time 2.5 years; p < 0.001) and were diagnosed with AD 2-3 years earlier (p < 0.001)., Discussion: The FCSRT assessment suite shows the best predictive performance in detecting AD in people with MCI. These findings might help to reliably and timely identify people at higher risk of AD that is crucial both for properly selecting participants to clinical trials and to fine tune an effective and patient-centered care.

Published
2018
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38. Living Alone and Dementia Incidence: A Clinical-Based Study in People With Mild Cognitive Impairment.

Author

Grande G, Vetrano DL, Cova I, Pomati S, Mattavelli D, Maggiore L, Cucumo V, Ghiretti R, Vanacore N, Mariani C, and Rizzuto D

Subjects
Aged, Aged, 80 and over, Dementia diagnosis, Disease Progression, Female, Humans, Incidence, Italy epidemiology, Longitudinal Studies, Male, Proportional Hazards Models, Risk, Cognitive Dysfunction epidemiology, Cognitive Dysfunction psychology, Dementia epidemiology, Dementia psychology, Independent Living, Loneliness
Abstract

Introduction: Social isolation and living alone have been associated with negative outcomes, especially in the older population. We aim to investigate the effect of living alone on the development of dementia in people with mild cognitive impairment (MCI)., Materials and Methods: In this longitudinal study, we enrolled 345 outpatients with MCI evaluated at baseline through a clinical and neuropsychological protocol. Data on living situation (living alone vs. living with someone) were also collected. The development of dementia at follow-up was the outcome of the study. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox regression analyses. Laplace regression was used to model the time-to-dementia diagnosis as a function of living situation., Results: During the follow-up time (mean [SD]: 2.8 [2.2] years), 172 (50%) participants developed dementia. After controlling for age, sex, years of education, MCI subtype, presence of comorbidities, and antidepressant therapy, people with MCI living alone were more likely to develop dementia (HR: 1.5; 95% CI: 1.1-2.1), when compared to those living with someone. In addition, participants with MCI living alone were diagnosed with dementia 1 year earlier than those living with someone ( P = .012)., Conclusion: Living alone increases by 50% the risk of developing dementia and anticipates by 1 year the diagnosis in people with MCI. These results, in line with findings of previous population-based studies, emphasize the pivotal role of the living situation in identifying a frailer share of the population at higher risk of dementia to which devote ad hoc assessment and care.

Published
2018
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39. Preclinical Development of a Novel, Orally-Administered Anti-Tumour Necrosis Factor Domain Antibody for the Treatment of Inflammatory Bowel Disease.

Author

Crowe JS, Roberts KJ, Carlton TM, Maggiore L, Cubitt MF, Clare S, Harcourt K, Reckless J, MacDonald TT, Ray KP, Vossenkämper A, and West MR

Subjects
Administration, Oral, Animals, Biomarkers blood, Colon metabolism, Colon pathology, Disease Models, Animal, Drug Evaluation, Preclinical, Humans, Ileum metabolism, Ileum pathology, Inflammatory Bowel Diseases chemically induced, Inflammatory Bowel Diseases pathology, Intestinal Mucosa pathology, Male, Mice, Tumor Necrosis Factor-alpha blood, Cytokines blood, Inflammatory Bowel Diseases blood, Inflammatory Bowel Diseases drug therapy, Infliximab pharmacokinetics, Infliximab pharmacology, Intestinal Mucosa metabolism, Tumor Necrosis Factor-alpha antagonists & inhibitors
Abstract

TNFα is an important cytokine in inflammatory bowel disease. V565 is a novel anti-TNFα domain antibody developed for oral administration in IBD patients, derived from a llama domain antibody and engineered to enhance intestinal protease resistance. V565 activity was evaluated in TNFα-TNFα receptor-binding ELISAs as well as TNFα responsive cellular assays and demonstrated neutralisation of both soluble and membrane TNFα with potencies similar to those of adalimumab. Although sensitive to pepsin, V565 retained activity after lengthy incubations with trypsin, chymotrypsin, and pancreatin, as well as mouse small intestinal and human ileal and faecal supernatants. In orally dosed naïve and DSS colitis mice, high V565 concentrations were observed in intestinal contents and faeces and immunostaining revealed V565 localisation in mouse colon tissue. V565 was detected by ELISA in post-dose serum of colitis mice, but not naïve mice, demonstrating penetration of disrupted epithelium. In an ex vivo human IBD tissue culture model, V565 inhibition of tissue phosphoprotein levels and production of inflammatory cytokine biomarkers was similar to infliximab, demonstrating efficacy when present at the disease site. Taken together, results of these studies provide confidence that oral V565 dosing will be therapeutic in IBD patients where the mucosal epithelial barrier is compromised.

Published
2018
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40. Self-Awareness for Memory Impairment in Amnestic Mild Cognitive Impairment: A Longitudinal Study.

Author

Cova I, Grande G, Cucumo V, Ghiretti R, Maggiore L, Galimberti D, Scarpini E, Mariani C, and Pomati S

Subjects
Aged, Agnosia, Alzheimer Disease diagnosis, Female, Humans, Longitudinal Studies, Male, Awareness physiology, Cognitive Dysfunction diagnosis, Neuropsychological Tests, Severity of Illness Index
Abstract

Aim: To assess memory impairment insight as a predictor of dementia and Alzheimer's disease (AD) in amnestic mild cognitive impairment (MCI)., Methods: To verify whether the awareness of memory impairment assessed by Geriatric Depression Scale (GDS) was associated with the risk of progression to dementia and AD in a cohort of MCI, we used a Cox regression model adjusted for age, sex, education, subtypes of amnestic MCI, Mini-Mental State Examination, Cumulative Illness Rating Scale severity index, and apolipoprotein E genotype., Results: During a follow-up of 27.7 (20.8) months, 205 (63.3%) of 324 patients with amnestic MCI progressed to dementia, including 141 to AD. No association was found in the unadjusted, partially adjusted (for sociodemographic variables), and fully adjusted multivariate Cox analysis between the awareness of memory impairment and the progression to dementia and AD., Discussion: Awareness or anosognosia of memory deficits, identified by GDS, is not useful to predict progression to dementia of patients with amnestic MCI.

Published
2017
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41. Nutritional status and body composition by bioelectrical impedance vector analysis: A cross sectional study in mild cognitive impairment and Alzheimer's disease.

Author

Cova I, Pomati S, Maggiore L, Forcella M, Cucumo V, Ghiretti R, Grande G, Muzio F, and Mariani C

Subjects
Aged, Case-Control Studies, Cross-Sectional Studies, Female, Humans, Male, Plethysmography, Impedance, Alzheimer Disease epidemiology, Body Composition, Cognitive Dysfunction epidemiology, Nutritional Status
Abstract

Aims: Analysis of nutritional status and body composition in Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI)., Methods: A cross-sectional study was performed in a University-Hospital setting, recruiting 59 patients with AD, 34 subjects with MCI and 58 elderly healthy controls (HC). Nutritional status was assessed by anthropometric parameters (body mass index; calf, upper arm and waist circumferences), Mini Nutritional Assessment (MNA) and body composition by bioelectrical impedance vector analysis (BIVA). Variables were analyzed by analysis of variance and subjects were grouped by cognitive status and gender., Results: Sociodemographic variables did not differ among the three groups (AD, MCI and HC), except for females' age, which was therefore used as covariate in a general linear multivariate model. MNA score was significantly lower in AD patients than in HC; MCI subjects achieved intermediate scores. AD patients (both sexes) had significantly (p<0.05) higher height-normalized impedance values and lower phase angles (body cell mass) compared with HC; a higher ratio of impedance to height was found in men with MCI with respect to HC. With BIVA method, MCI subjects showed a significant displacement on the RXc graph on the right side indicating lower soft tissues (Hotelling's T2 test: men = 10.6; women = 7.9;p < 0,05) just like AD patients (Hotelling's T2 test: men = 18.2; women = 16.9; p<0,001)., Conclusion: Bioelectrical parameters significantly differ from MCI and AD to HC; MCI showed an intermediate pattern between AD and HC. Longitudinal studies are required to investigate if BIVA could reflect early AD-changes in body composition in subjects with MCI., Competing Interests: The authors have declared that no competing interests exist.

Published
2017
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42. Weight Loss Predicts Progression of Mild Cognitive Impairment to Alzheimer's Disease.

Author

Cova I, Clerici F, Rossi A, Cucumo V, Ghiretti R, Maggiore L, Pomati S, Galimberti D, Scarpini E, Mariani C, and Caracciolo B

Subjects
Aged, Biomarkers, Body Weight physiology, Diagnostic and Statistical Manual of Mental Disorders, Disease Progression, Female, Humans, Male, Neuropsychological Tests, Prognosis, Alzheimer Disease epidemiology, Cognitive Dysfunction epidemiology, Dementia, Vascular epidemiology, Lewy Body Disease epidemiology, Weight Loss physiology
Abstract

Background: Weight loss is common in people with Alzheimer's disease (AD) and it could be a marker of impending AD in Mild Cognitive Impairment (MCI) and improve prognostic accuracy, if accelerated progression to AD would be shown., Aims: To assess weight loss as a predictor of dementia and AD in MCI., Methods: One hundred twenty-five subjects with MCI (age 73.8 ± 7.1 years) were followed for an average of 4 years. Two weight measurements were carried out at a minimum time interval of one year. Dementia was defined according to DSM-IV criteria and AD according to NINCDS-ADRDA criteria. Weight loss was defined as a ≥4% decrease in baseline weight., Results: Fifty-three (42.4%) MCI progressed to dementia, which was of the AD-type in half of the cases. Weight loss was associated with a 3.4-fold increased risk of dementia (95% CI = 1.5-6.9) and a 3.2-fold increased risk of AD (95% CI = 1.4-8.3). In terms of years lived without disease, weight loss was associated to a 2.3 and 2.5 years earlier onset of dementia and AD., Conclusions: Accelerated progression towards dementia and AD is expected when weight loss is observed in MCI patients. Weight should be closely monitored in elderly with mild cognitive impairment.

Published
2016
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43. Quantitative proteomic analysis of Shigella flexneri and Shigella sonnei Generalized Modules for Membrane Antigens (GMMA) reveals highly pure preparations.

Author

Maggiore L, Yu L, Omasits U, Rossi O, Dougan G, Thomson NR, Saul A, Choudhary JS, and Gerke C

Subjects
Antigens, Bacterial genetics, Antigens, Surface genetics, Bacterial Vaccines, Cell Membrane immunology, Cell Membrane ultrastructure, Dysentery, Bacillary prevention & control, Membrane Proteins immunology, Periplasmic Proteins immunology, Shigella flexneri ultrastructure, Shigella sonnei ultrastructure, Antigens, Bacterial analysis, Antigens, Surface analysis, Proteomics, Shigella flexneri immunology, Shigella sonnei immunology
Abstract

Outer membrane blebs are naturally shed by Gram-negative bacteria and are candidates of interest for vaccines development. Genetic modification of bacteria to induce hyperblebbing greatly increases the yield of blebs, called Generalized Modules for Membrane Antigens (GMMA). The composition of the GMMA from hyperblebbing mutants of Shigella flexneri 2a and Shigella sonnei were quantitatively analyzed using high-sensitivity mass spectrometry with the label-free iBAQ procedure and compared to the composition of the solubilized cells of the GMMA-producing strains. There were 2306 proteins identified, 659 in GMMA and 2239 in bacteria, of which 290 (GMMA) and 1696 (bacteria) were common to both S. flexneri 2a and S. sonnei. Predicted outer membrane and periplasmic proteins constituted 95.7% and 98.7% of the protein mass of S. flexneri 2a and S. sonnei GMMA, respectively. Among the remaining proteins, small quantities of ribosomal proteins collectively accounted for more than half of the predicted cytoplasmic protein impurities in the GMMA. In GMMA, the outer membrane and periplasmic proteins were enriched 13.3-fold (S. flexneri 2a) and 8.3-fold (S. sonnei) compared to their abundance in the parent bacteria. Both periplasmic and outer membrane proteins were enriched similarly, suggesting that GMMA have a similar surface to volume ratio as the surface to periplasmic volume ratio in these mutant bacteria. Results in S. flexneri 2a and S. sonnei showed high reproducibility indicating a robust GMMA-producing process and the low contamination by cytoplasmic proteins support the use of GMMA for vaccines. Data are available via ProteomeXchange with identifier PXD002517., (Copyright © 2015 The Authors. Published by Elsevier GmbH.. All rights reserved.)

Published
2016
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44. Reversible Mild Cognitive Impairment: The Role of Comorbidities at Baseline Evaluation.

Author

Grande G, Cucumo V, Cova I, Ghiretti R, Maggiore L, Lacorte E, Galimberti D, Scarpini E, Clerici F, Pomati S, Vanacore N, and Mariani C

Subjects
Analysis of Variance, Cohort Studies, Comorbidity, Female, Humans, Male, Memory, Mental Status Schedule, Neuropsychological Tests, Reference Values, Verbal Learning, Cognitive Dysfunction epidemiology
Abstract

The prognostic value of mild cognitive impairment (MCI) is being questioned, with some MCI subjects reverting to normal cognition (NC). The reversion rate varies mostly depending on the study design, the setting, and both MCI and NC definitions. Previous studies have focused on the profile of subjects who revert to NC, but the role of comorbidities has not been entirely investigated. We aimed to evaluate the proportion of MCI subjects who revert to NC in a memory clinic context, focusing on the role of comorbidities. Between 2004 and 2013, 374 MCI subjects were recruited. During a mean time of 32 ± 25.5 months, 21 subjects (5.6%) reverted to NC. Subjects who reverted to NC were younger (p = 0.0001), more educated (p = 0.0001), had a better global cognition (p = 0.0001), as assessed by the Mini-Mental State Examination (MMSE) and suffered from more comorbidities (p = 0.002), as assessed by Cumulative Illness Rating Scale (CIRS) than those who developed dementia. The Cox Regression Model, constructed to adjust for the confounders, showed that the higher were the MMSE (HR = 1.83, CI 95%: 1.07-3.11) and the CIRS score (HR = 1.3, CI 95% 0.88-1.92) at baseline, the higher was the probability of returning to NC than developing dementia, though the last association was not significant. Subjects who reverted to NC were more frequently affected by respiratory (p = 0.002), urologic (p = 0.012), and psychiatric (p = 0.012) diseases. The cognitive performance of subjects with medical comorbidities could benefit from preventive strategies aimed at treating the underlying diseases.

Published
2016
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45. Body Mass Index Predicts Progression of Mild Cognitive Impairment to Dementia.

Author

Cova I, Clerici F, Maggiore L, Pomati S, Cucumo V, Ghiretti R, Galimberti D, Scarpini E, Mariani C, and Caracciolo B

Subjects
Aged, Body Mass Index, Cognitive Dysfunction psychology, Dementia complications, Dementia psychology, Diagnostic and Statistical Manual of Mental Disorders, Disease Progression, Female, Follow-Up Studies, Humans, Male, Prognosis, Proportional Hazards Models, Alzheimer Disease epidemiology, Cognitive Dysfunction complications, Dementia epidemiology
Abstract

Aims: To examine the relationship between body mass index (BMI) and progression to dementia and Alzheimer's disease (AD) in mild cognitive impairment (MCI)., Materials and Methods: Two hundred and twenty-eight MCI subjects (mean age 74.04 ± 6.94 years; 57% female) from a memory clinic were followed for 2.40 ± 1.58 years. Baseline height and weight were used to calculate the BMI. The main outcome was progression to dementia (DSM-IV criteria) and AD (NINCDS-ADRDA criteria). Cox proportional hazard models were used to assess the longitudinal association of BMI with dementia and AD, adjusting for a comprehensive set of covariates, including vascular risk factors/diseases and neuroimaging profiles., Results: Out of 228 subjects with MCI, 117 (51.3%) progressed to dementia. Eighty-nine (76%) of the incident dementia cases had AD. In both unadjusted and multi-adjusted models, a higher BMI was associated with a reduced risk of dementia (multi-adjusted HR 0.9; 95% CI 0.8-0.9) and AD (multi-adjusted HR 0.9; 95% CI 0.8-0.9). Being underweight increased the risk of all types of dementia (multi-adjusted HR 2.5; 95% CI 1.2-5.1) but was not specifically associated with AD (multi-adjusted HR 2.2; 95% CI 0.9-5.3)., Conclusions: BMI predicted progression of MCI to dementia and AD. In particular, a higher BMI was associated with a lower risk of dementia and AD, and underweight was associated with a higher risk of dementia. BMI assessment may improve the prognostic accuracy of MCI in clinical practice., (© 2016 S. Karger AG, Basel.)

Published
2016
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46. Comparison of colorimetric assays with quantitative amino acid analysis for protein quantification of Generalized Modules for Membrane Antigens (GMMA).

Author

Rossi O, Maggiore L, Necchi F, Koeberling O, MacLennan CA, Saul A, and Gerke C

Subjects
Animals, Cattle, Color, Electrophoresis, Polyacrylamide Gel, Genotype, Phenotype, Reproducibility of Results, Amino Acids analysis, Antigens, Bacterial analysis, Cell Membrane metabolism, Colorimetry methods, Serum Albumin, Bovine analysis
Abstract

Genetically induced outer membrane particles from Gram-negative bacteria, called Generalized Modules for Membrane Antigens (GMMA), are being investigated as vaccines. Rapid methods are required for estimating the protein content for in-process assays during production. Since GMMA are complex biological structures containing lipid and polysaccharide as well as protein, protein determinations are not necessarily straightforward. We compared protein quantification by Bradford, Lowry, and Non-Interfering assays using bovine serum albumin (BSA) as standard with quantitative amino acid (AA) analysis, the most accurate currently available method for protein quantification. The Lowry assay has the lowest inter- and intra-assay variation and gives the best linearity between protein amount and absorbance. In all three assays, the color yield (optical density per mass of protein) of GMMA was markedly different from that of BSA with a ratio of approximately 4 for the Bradford assay, and highly variable between different GMMA; and approximately 0.7 for the Lowry and Non-Interfering assays, highlighting the need for calibrating the standard used in the colorimetric assay against GMMA quantified by AA analysis. In terms of a combination of ease, reproducibility, and proportionality of protein measurement, and comparability between samples, the Lowry assay was superior to Bradford and Non-Interfering assays for GMMA quantification.

Published
2015
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47. Physical activity reduces the risk of dementia in mild cognitive impairment subjects: a cohort study.

Author

Grande G, Vanacore N, Maggiore L, Cucumo V, Ghiretti R, Galimberti D, Scarpini E, Mariani C, and Clerici F

Subjects
Aged, Aged, 80 and over, Cognitive Dysfunction epidemiology, Dementia epidemiology, Exercise physiology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Risk Factors, Cognitive Dysfunction psychology, Cognitive Dysfunction therapy, Dementia psychology, Dementia therapy, Life Style, Motor Activity physiology
Abstract

Background: Leisure activities, particularly exercise, play a protective role against dementia in healthy people, but it is unknown if this protective effect could be generalized to subjects with mild cognitive impairment (MCI)., Objective: To investigate the influence of leisure activities on the risk of progression of MCI to dementia., Methods: 176 MCI subjects attending a memory clinic underwent a standardized lifestyle questionnaire between October 2007 and May 2010. Social, cognitive, and physical scores were derived based on the assiduity of interpersonal contacts and on the frequency of participation in individual leisure activities. Subjects were requested to return every 12 months for dementia surveillance. The outcome measure was the risk of dementia associated with social, cognitive, and physical scores., Results: Over a median follow-up time of 2.59 year, 92 (52.2%) MCI subjects developed dementia. Subjects with physical scores in the highest third had a lower risk (HR 0.44; 95% CI 0.23-0.85) of dementia compared with those in the lowest third. No association was found between cognitive or social scores and the risk of dementia., Conclusion: To our knowledge, this is the first prospective clinical study which demonstrates that high levels of participation in physical leisure activities are associated with reduced risk of dementia in subjects with MCI. In line with findings coming from community-based studies on healthy elderly, our finding suggests that the protective role of exercise against the development of dementia can be generalized to MCI subjects seen in clinical practice. Clinicians should encourage MCI subjects to participate in physical leisure activities.

Published
2014
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48. High yield production process for Shigella outer membrane particles.

Author

Berlanda Scorza F, Colucci AM, Maggiore L, Sanzone S, Rossi O, Ferlenghi I, Pesce I, Caboni M, Norais N, Di Cioccio V, Saul A, and Gerke C

Subjects
Animals, Antigens, Surface isolation & purification, Blotting, Western, Computational Biology, DNA Primers genetics, Electrophoresis, Gel, Two-Dimensional, Enzyme-Linked Immunosorbent Assay, Female, Fermentation, Gene Knockout Techniques, Mice, Microscopy, Electron, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization, Vaccines biosynthesis, Bacterial Outer Membrane Proteins metabolism, Biotechnology methods, Membrane Lipids metabolism, Protein Engineering methods, Shigella sonnei metabolism
Abstract

Gram-negative bacteria naturally shed particles that consist of outer membrane lipids, outer membrane proteins, and soluble periplasmic components. These particles have been proposed for use as vaccines but the yield has been problematic. We developed a high yielding production process of genetically derived outer membrane particles from the human pathogen Shigella sonnei. Yields of approximately 100 milligrams of membrane-associated proteins per liter of fermentation were obtained from cultures of S. sonnei ΔtolR ΔgalU at optical densities of 30-45 in a 5 L fermenter. Proteomic analysis of the purified particles showed the preparation to primarily contain predicted outer membrane and periplasmic proteins. These were highly immunogenic in mice. The production of these outer membrane particles from high density cultivation of bacteria supports the feasibility of scaling up this approach as an affordable manufacturing process. Furthermore, we demonstrate the feasibility of using this process with other genetic manipulations e.g. abolition of O antigen synthesis and modification of the lipopolysaccharide structure in order to modify the immunogenicity or reactogenicity of the particles. This work provides the basis for a large scale manufacturing process of Generalized Modules of Membrane Antigens (GMMA) for production of vaccines from gram-negative bacteria.

Published
2012
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49. Does vascular burden contribute to the progression of mild cognitive impairment to dementia?

Author

Clerici F, Caracciolo B, Cova I, Fusari Imperatori S, Maggiore L, Galimberti D, Scarpini E, Mariani C, and Fratiglioni L

Subjects
Aged, Aged, 80 and over, Analysis of Variance, Cognitive Dysfunction physiopathology, Disease Progression, Female, Humans, Hypertension physiopathology, Leukoencephalopathies physiopathology, Male, Neuropsychological Tests, Proportional Hazards Models, Risk, Risk Factors, Vascular Diseases physiopathology, Cognitive Dysfunction complications, Dementia etiology, Hypertension complications, Leukoencephalopathies complications, Vascular Diseases complications
Abstract

Aims: To investigate the contribution of vascular risk factors (VRFs), vascular diseases (VDs) and white matter lesions (WMLs) to the progression of mild cognitive impairment (MCI) to dementia and Alzheimer's disease (AD)., Methods: Two hundred forty-five consecutive subjects with MCI (age 74.09 ± 6.92 years) were followed for an average of 2.4 years. The Hachinski Ischemic Score and the Framingham Stroke Risk Profile were used to summarize VRFs and VDs. WMLs were graded using the Age-Related White Matter Changes Scale., Results: One hundred twenty-nine (52.6%) out of 245 subjects at risk converted to dementia, including 87 cases of AD. When hypertension occurred in MCI with deep WMLs, a 1.8-fold increased risk of dementia was observed (95% CI = 1.0-3.4). When deep WMLs occurred in MCI with high scores (≥4) on the Hachinski scale, a 3.5-fold (95% CI = 1.6-7.4) and 3.8-fold (95% CI = 1.2-11.5) risk of progression to dementia and AD was observed, respectively. Analogously, the joint effect of WMLs and high scores (≥14) on the Framingham scale nearly doubled the risk of dementia (hazard ratio = 1.9, 95% CI = 1.1-3.3)., Conclusions: Accelerated progression of MCI to dementia and AD is to be expected when VRFs and VDs occur together with WMLs., (Copyright © 2012 S. Karger AG, Basel.)

Published
2012
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50. How are the interests of incapacitated research participants protected through legislation? An Italian study on legal agency for dementia patients.

Author

Gainotti S, Fusari Imperatori S, Spila-Alegiani S, Maggiore L, Galeotti F, Vanacore N, Petrini C, Raschetti R, Mariani C, and Clerici F

Subjects
Humans, Italy, Dementia therapy, Human Experimentation legislation & jurisprudence
Abstract

Background: Patients with dementia may have limited capacity to give informed consent to participate in clinical research. One possible way to safeguard the patients' interests in research is the involvement of a proxy in the recruitment process. In Italy, the system of proxy is determined by the courts. In this study we evaluate the timing for appointment of a legal proxy in Italy and identify predictive variables of appointment., Methodology/principal Findings: Subjects were recruited among the outpatients seeking medical advice for cognitive complaints at the Centre for Research and Treatment of Cognitive Dysfunctions, University of Milan, "Luigi Sacco" Hospital. The Centre was participating to the AdCare Study, a no-profit randomised clinical trial coordinated by the Italian National Institute of Health. The requirement that informed consent be given by a legal representative dramatically slowed down the recruitment process in AdCare, which was prematurely interrupted. The Centre for Research and Treatment of Cognitive Dysfunctions collected data on the timing required to appoint the legal representatives. Patients diagnosed with dementia and their caregivers were provided information on the Italian law on legal agency (law 6/2004). At each scheduled check-up the caregiver was asked whether she/he had applied to appoint a legal proxy for the patient and the time interval between the presentation of the law, the registration of the application at the law court chancellery and the sentence of appointment was registered. The study involved 169 demented patients. Seventy-eight patients (46.2%) applied to appoint a legal proxy. These subjects were usually younger, had been suffering from dementia for a longer time, had less than two children and made more use of memantine. The mean interval time between the presentation of the law and the patients' application to the law court chancellery was two months. The mean interval time between the patient's application to the law court chancellery and the sentence of appointment was four months., Conclusions/significance: In Italy the requirement that legal representatives be appointed by the courts slows down subjects' participation in research. Other procedures for legal agency of the incapacitated patients may be adopted, taking as examples other EU countries' systems.

Published
2010
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