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1. Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ): Rationale and Study Design of the Largest Global Prospective Cohort Study of Clinical High Risk for Psychosis

Author

Wannan, CMJ, Nelson, B, Addington, J, Allott, K, Anticevic, A, Arango, C, Baker, JT, Bearden, CE, Billah, T, Bouix, S, Broome, MR, Buccilli, K, Cadenhead, KS, Calkins, ME, Cannon, TD, Cecci, G, Chen, EYH, Cho, KIK, Choi, J, Clark, SR, Coleman, MJ, Conus, P, Corcoran, CM, Cornblatt, BA, Diaz-Caneja, CM, Dwyer, D, Ebdrup, BH, Ellman, LM, Fusar-Poli, P, Galindo, L, Gaspar, PA, Gerber, C, Glenthoj, LB, Glynn, R, Harms, MP, Horton, LE, Kahn, RS, Kambeitz, J, Kambeitz-Ilankovic, L, Kane, JM, Kapur, T, Keshavan, MS, Kim, S-W, Koutsouleris, N, Kubicki, M, Kwon, JS, Langbein, K, Lewandowski, KE, Light, GA, Mamah, D, Marcy, PJ, Mathalon, DH, McGorry, PD, Mittal, VA, Nordentoft, M, Nunez, A, Pasternak, O, Pearlson, GD, Perez, J, Perkins, DO, Powers, AR, Roalf, DR, Sabb, FW, Schiffman, J, Shah, JL, Smesny, S, Spark, J, Stone, WS, Strauss, GP, Tamayo, Z, Torous, J, Upthegrove, R, Vangel, M, Verma, S, Wang, J, Winter-van Rossum, I, Wolf, DH, Wolff, P, Wood, SJ, Yung, AR, Agurto, C, Alvarez-Jimenez, M, Amminger, P, Armando, M, Asgari-Targhi, A, Cahill, J, Carrion, RE, Castro, E, Cetin-Karayumak, S, Chakravarty, MM, Cho, YT, Cotter, D, D'Alfonso, S, Ennis, M, Fadnavis, S, Fonteneau, C, Gao, C, Gupta, T, Gur, RE, Gur, RC, Hamilton, HK, Hoftman, GD, Jacobs, GR, Jarcho, J, Ji, JL, Kohler, CG, Lalousis, PA, Lavoie, S, Lepage, M, Liebenthal, E, Mervis, J, Murty, V, Nicholas, SC, Ning, L, Penzel, N, Poldrack, R, Polosecki, P, Pratt, DN, Rabin, R, Eichi, HR, Rathi, Y, Reichenberg, A, Reinen, J, Rogers, J, Ruiz-Yu, B, Scott, I, Seitz-Holland, J, Srihari, VH, Srivastava, A, Thompson, A, Turetsky, BI, Walsh, BC, Whitford, T, Wigman, JTW, Yao, B, Yuen, HP, Ahmed, U, Byun, AJS, Chung, Y, Do, K, Hendricks, L, Huynh, K, Jeffries, C, Lane, E, Langholm, C, Lin, E, Mantua, V, Santorelli, G, Ruparel, K, Zoupou, E, Adasme, T, Addamo, L, Adery, L, Ali, M, Auther, A, Aversa, S, Baek, S-H, Bates, K, Bathery, A, Bayer, JMM, Beedham, R, Bilgrami, Z, Birch, S, Bonoldi, I, Borders, O, Borgatti, R, Brown, L, Bruna, A, Carrington, H, Castillo-Passi, RI, Chen, J, Cheng, N, Ching, AE, Clifford, C, Colton, B-L, Contreras, P, Corral, S, Damiani, S, Done, M, Estrade, A, Etuka, BA, Formica, M, Furlan, R, Geljic, M, Germano, C, Getachew, R, Goncalves, M, Haidar, A, Hartmann, J, Jo, A, John, O, Kerins, S, Kerr, M, Kesselring, I, Kim, H, Kim, N, Kinney, K, Krcmar, M, Kotler, E, Lafanechere, M, Lee, C, Llerena, J, Markiewicz, C, Matnejl, P, Maturana, A, Mavambu, A, Mayol-Troncoso, R, McDonnell, A, McGowan, A, McLaughlin, D, McIlhenny, R, McQueen, B, Mebrahtu, Y, Mensi, M, Hui, CLM, Suen, YN, Wong, SMY, Morrell, N, Omar, M, Partridge, A, Phassouliotis, C, Pichiecchio, A, Politi, P, Porter, C, Provenzani, U, Prunier, N, Raj, J, Ray, S, Rayner, V, Reyes, M, Reynolds, K, Rush, S, Salinas, C, Shetty, J, Snowball, C, Tod, S, Turra-Farina, G, Valle, D, Veale, S, Whitson, S, Wickham, A, Youn, S, Zamorano, F, Zavaglia, E, Zinberg, J, Woods, SW, Shenton, ME, Wannan, CMJ, Nelson, B, Addington, J, Allott, K, Anticevic, A, Arango, C, Baker, JT, Bearden, CE, Billah, T, Bouix, S, Broome, MR, Buccilli, K, Cadenhead, KS, Calkins, ME, Cannon, TD, Cecci, G, Chen, EYH, Cho, KIK, Choi, J, Clark, SR, Coleman, MJ, Conus, P, Corcoran, CM, Cornblatt, BA, Diaz-Caneja, CM, Dwyer, D, Ebdrup, BH, Ellman, LM, Fusar-Poli, P, Galindo, L, Gaspar, PA, Gerber, C, Glenthoj, LB, Glynn, R, Harms, MP, Horton, LE, Kahn, RS, Kambeitz, J, Kambeitz-Ilankovic, L, Kane, JM, Kapur, T, Keshavan, MS, Kim, S-W, Koutsouleris, N, Kubicki, M, Kwon, JS, Langbein, K, Lewandowski, KE, Light, GA, Mamah, D, Marcy, PJ, Mathalon, DH, McGorry, PD, Mittal, VA, Nordentoft, M, Nunez, A, Pasternak, O, Pearlson, GD, Perez, J, Perkins, DO, Powers, AR, Roalf, DR, Sabb, FW, Schiffman, J, Shah, JL, Smesny, S, Spark, J, Stone, WS, Strauss, GP, Tamayo, Z, Torous, J, Upthegrove, R, Vangel, M, Verma, S, Wang, J, Winter-van Rossum, I, Wolf, DH, Wolff, P, Wood, SJ, Yung, AR, Agurto, C, Alvarez-Jimenez, M, Amminger, P, Armando, M, Asgari-Targhi, A, Cahill, J, Carrion, RE, Castro, E, Cetin-Karayumak, S, Chakravarty, MM, Cho, YT, Cotter, D, D'Alfonso, S, Ennis, M, Fadnavis, S, Fonteneau, C, Gao, C, Gupta, T, Gur, RE, Gur, RC, Hamilton, HK, Hoftman, GD, Jacobs, GR, Jarcho, J, Ji, JL, Kohler, CG, Lalousis, PA, Lavoie, S, Lepage, M, Liebenthal, E, Mervis, J, Murty, V, Nicholas, SC, Ning, L, Penzel, N, Poldrack, R, Polosecki, P, Pratt, DN, Rabin, R, Eichi, HR, Rathi, Y, Reichenberg, A, Reinen, J, Rogers, J, Ruiz-Yu, B, Scott, I, Seitz-Holland, J, Srihari, VH, Srivastava, A, Thompson, A, Turetsky, BI, Walsh, BC, Whitford, T, Wigman, JTW, Yao, B, Yuen, HP, Ahmed, U, Byun, AJS, Chung, Y, Do, K, Hendricks, L, Huynh, K, Jeffries, C, Lane, E, Langholm, C, Lin, E, Mantua, V, Santorelli, G, Ruparel, K, Zoupou, E, Adasme, T, Addamo, L, Adery, L, Ali, M, Auther, A, Aversa, S, Baek, S-H, Bates, K, Bathery, A, Bayer, JMM, Beedham, R, Bilgrami, Z, Birch, S, Bonoldi, I, Borders, O, Borgatti, R, Brown, L, Bruna, A, Carrington, H, Castillo-Passi, RI, Chen, J, Cheng, N, Ching, AE, Clifford, C, Colton, B-L, Contreras, P, Corral, S, Damiani, S, Done, M, Estrade, A, Etuka, BA, Formica, M, Furlan, R, Geljic, M, Germano, C, Getachew, R, Goncalves, M, Haidar, A, Hartmann, J, Jo, A, John, O, Kerins, S, Kerr, M, Kesselring, I, Kim, H, Kim, N, Kinney, K, Krcmar, M, Kotler, E, Lafanechere, M, Lee, C, Llerena, J, Markiewicz, C, Matnejl, P, Maturana, A, Mavambu, A, Mayol-Troncoso, R, McDonnell, A, McGowan, A, McLaughlin, D, McIlhenny, R, McQueen, B, Mebrahtu, Y, Mensi, M, Hui, CLM, Suen, YN, Wong, SMY, Morrell, N, Omar, M, Partridge, A, Phassouliotis, C, Pichiecchio, A, Politi, P, Porter, C, Provenzani, U, Prunier, N, Raj, J, Ray, S, Rayner, V, Reyes, M, Reynolds, K, Rush, S, Salinas, C, Shetty, J, Snowball, C, Tod, S, Turra-Farina, G, Valle, D, Veale, S, Whitson, S, Wickham, A, Youn, S, Zamorano, F, Zavaglia, E, Zinberg, J, Woods, SW, and Shenton, ME

Abstract

This article describes the rationale, aims, and methodology of the Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ). This is the largest international collaboration to date that will develop algorithms to predict trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the development and use of novel pharmacological interventions for CHR individuals. We present a description of the participating research networks and the data processing analysis and coordination center, their processes for data harmonization across 43 sites from 13 participating countries (recruitment across North America, Australia, Europe, Asia, and South America), data flow and quality assessment processes, data analyses, and the transfer of data to the National Institute of Mental Health (NIMH) Data Archive (NDA) for use by the research community. In an expected sample of approximately 2000 CHR individuals and 640 matched healthy controls, AMP SCZ will collect clinical, environmental, and cognitive data along with multimodal biomarkers, including neuroimaging, electrophysiology, fluid biospecimens, speech and facial expression samples, novel measures derived from digital health technologies including smartphone-based daily surveys, and passive sensing as well as actigraphy. The study will investigate a range of clinical outcomes over a 2-year period, including transition to psychosis, remission or persistence of CHR status, attenuated positive symptoms, persistent negative symptoms, mood and anxiety symptoms, and psychosocial functioning. The global reach of AMP SCZ and its harmonized innovative methods promise to catalyze the development of new treatments to address critical unmet clinical and public health needs in CHR individuals.

Published
2024

2. Clinical trials and late‐stage drug development for Alzheimer's disease: an appraisal from 1984 to 2014

Author

Schneider, LS, Mangialasche, F, Andreasen, N, Feldman, H, Giacobini, E, Jones, R, Mantua, V, Mecocci, P, Pani, L, Winblad, B, and Kivipelto, M

Subjects
Patient Safety, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Clinical Trials and Supportive Activities, Aging, Acquired Cognitive Impairment, Neurosciences, Brain Disorders, Clinical Research, Dementia, Neurodegenerative, Alzheimer's Disease, 5.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Alzheimer Disease, Biomarkers, Cholinesterase Inhibitors, Dopamine Agents, Drug Monitoring, Humans, Medication Therapy Management, Memantine, Memory Disorders, Nootropic Agents, Practice Guidelines as Topic, Randomized Controlled Trials as Topic, Alzheimer, clinical trial, dementia, drug development, treatment, Clinical Sciences, Cardiovascular System & Hematology
Abstract

The modern era of drug development for Alzheimer's disease began with the proposal of the cholinergic hypothesis of memory impairment and the 1984 research criteria for Alzheimer's disease. Since then, despite the evaluation of numerous potential treatments in clinical trials, only four cholinesterase inhibitors and memantine have shown sufficient safety and efficacy to allow marketing approval at an international level. Although this is probably because the other drugs tested were ineffective, inadequate clinical development methods have also been blamed for the failures. Here, we review the development of treatments for Alzheimer's disease during the past 30 years, considering the drugs, potential targets, late-stage clinical trials, development methods, emerging use of biomarkers and evolution of regulatory considerations in order to summarize advances and anticipate future developments. We have considered late-stage Alzheimer's disease drug development from 1984 to 2013, including individual clinical trials, systematic and qualitative reviews, meta-analyses, methods, commentaries, position papers and guidelines. We then review the evolution of drugs in late clinical development, methods, biomarkers and regulatory issues. Although a range of small molecules and biological products against many targets have been investigated in clinical trials, the predominant drug targets have been the cholinergic system and the amyloid cascade. Trial methods have evolved incrementally: inclusion criteria have largely remained focused on mild-to-moderate Alzheimer's disease criteria, recently extending to early or prodromal Alzheimer disease or 'mild cognitive impairment due to Alzheimer's disease', for drugs considered to be disease modifying. The duration of trials has remained at 6-12 months for drugs intended to improve symptoms; 18- to 24-month trials have been established for drugs expected to attenuate clinical course. Cognitive performance, activities of daily living, global change and severity ratings have persisted as the primary clinically relevant outcomes. Regulatory guidance and oversight have evolved to allow for enrichment of early-stage Alzheimer's disease trial samples using biomarkers and phase-specific outcomes. In conclusion, validated drug targets for Alzheimer's disease remain to be developed. Only drugs that affect an aspect of cholinergic function have shown consistent, but modest, clinical effects in late-phase trials. There is opportunity for substantial improvements in drug discovery and clinical development methods.

Published
2014

3. Is it time to revise the diagnostic criteria for apathy in brain disorders? the 2018 international consensus group

Author

Robert, P, Lanctôt, K, Agüera-Ortiz, L, Aalten, P, Bremond, F, Defrancesco, M, Hanon, C, David, R, Dubois, B, Dujardin, K, Husain, M, König, A, Levy, R, Mantua, V, Meulien, D, Miller, D, Moebius, H, Rasmussen, J, Robert, G, Ruthirakuhan, M, Stella, F, Yesavage, J, Zeghari, R, Manera, V, Cognition Behaviour Technology (CobTek), Université Côte d'Azur (UCA)-Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Centre Hospitalier Universitaire de Nice (CHU Nice)-Institut Claude Pompidou [Nice] (ICP - Nice), Sunnybrook Research Institute [Toronto] (SRI), Sunnybrook Health Sciences Centre, Centro de Investigación Biomédica en Red Salud Mental [Madrid] (CIBER-SAM), School for Mental Health and Neuroscience - Alzheimer Center Limburg (MUMC), Maastricht University [Maastricht], Spatio-Temporal Activity Recognition Systems (STARS), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), Innsbruck Medical University [Austria] (IMU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut de la Mémoire et de la Maladie d'Alzheimer [Paris] (IM2A), Université Pierre et Marie Curie - Paris 6 (UPMC), Troubles cognitifs dégénératifs et vasculaires - U 1171 (TCDV), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Institut National de la Santé et de la Recherche Médicale (INSERM), John Radcliffe Hospital [Oxford University Hospital], CIC AP-HP [CHU Pitié-Salpêtrière], Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Agenzia Italiana del Farmaco, Lundbeck SAS, Bracket, Moebius-Consult GmbH, Medcom [Odense], Service d'urologie [Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Universidade Estadual Paulista Júlio de Mesquita Filho = São Paulo State University (UNESP), Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University, ANR-15-IDEX-0001,UCA JEDI,Idex UCA JEDI(2015), Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Centre Hospitalier Universitaire de Nice (CHU Nice)-Institut Claude Pompidou [Nice] (ICP - Nice)-Université Côte d'Azur (UCA), Institut de la Mémoire et de la Maladie d'Alzheimer [CHU Pitié-Salpétriêre] (IM2A), Université Pierre et Marie Curie - Paris 6 (UPMC)-CHU Pitié-Salpêtrière [AP-HP], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Innsbruck Medical University = Medizinische Universität Innsbruck (IMU), Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 (TCDV), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), University Cote d'Azur, University of Toronto, Hospital Universitario 12 de Octubre & Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Alzheimer Center Limburg, STARS team - INRIA Sophia Antipolis, Innsbruck Medical University, Paris Descartes University, Sorbonne University, Inserm U1171, University of Oxford, Sorbonne Universités, Clinical Research Neurology Lundbeck SAS, moebius-consult GmbH, psi-napse, Université de Rennes 1, Universidade Estadual Paulista (Unesp), Stanford University, Université Nice Sophia Antipolis (... - 2019) (UNS), Université Côte d'Azur (UCA)-Université Côte d'Azur (UCA)-Centre Hospitalier Universitaire de Nice (CHU Nice)-Institut Claude Pompidou [Nice] (ICP - Nice), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Troubles cognitifs dégénératifs et vasculaires (U1171), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-INSERM, CIC AP-HP (pitie-Salpetriere)/inserm, Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut des Neurosciences Cliniques de Rennes (INCR)-CHU Pontchaillou [Rennes]-Université européenne de Bretagne - European University of Brittany (UEB)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Universidade Estadual Paulista Júlio de Mesquita Filho [São José do Rio Preto] (UNESP), Stanford University School of Medicine [Stanford], Stanford University [Stanford], RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Psychiatrie & Neuropsychologie, CHU Lille, CNRS, Inserm, Université de Lille, Troubles cognitifs dégénératifs et vasculaires - U1171, and Troubles cognitifs dégénératifs et vasculaires - U 1171 [TCDV]

Subjects
Emotion, MILD COGNITIVE IMPAIRMENT, Brain Diseases, Motivation, SYMPTOMS, MOTOR-ACTIVITY, International Cooperation, [SDV]Life Sciences [q-bio], Apathy, DEPRESSION, Neuropsychiatry, Social interaction, ALZHEIMERS-DISEASE, Treatment, PARKINSONS-DISEASE, CLINICAL-PRACTICE, RATING-SCALE LARS, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Behaviour, Brain disorders, Humans, France, METAANALYSIS, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Made available in DSpace on 2018-12-11T17:22:11Z (GMT). No. of bitstreams: 0 Previous issue date: 2018-10-01 Background: Apathy is a very common behavioural and psychological symptom across brain disorders. In the last decade, there have been considerable advances in research on apathy and motivation. It is thus important to revise the apathy diagnostic criteria published in 2009. The main objectives were to: a) revise the definition of apathy; b) update the list of apathy dimensions; c) operationalise the diagnostic criteria; and d) suggest appropriate assessment tools including new technologies. Methods: The expert panel (N = 23) included researchers and health care professionals working on brain disorders and apathy, a representative of a regulatory body, and a representative of the pharmaceutical industry. The revised diagnostic criteria for apathy were developed in a two-step process. First, following the standard Delphi methodology, the experts were asked to answer questions via web-survey in two rounds. Second, all the collected information was discussed on the occasion of the 26th European Congress of Psychiatry held in Nice (France). Results: Apathy was defined as a quantitative reduction of goal-directed activity in comparison to the patient's previous level of functioning (criterion A). Symptoms must persist for at least four weeks, and affect at least two of the three apathy dimensions (behaviour/cognition; emotion; social interaction; criterion B). Apathy should cause identifiable functional impairments (criterion C), and should not be fully explained by other factors, such as effects of a substance or major changes in the patient's environment (Criterion D). Conclusions: The new diagnostic criteria for apathy provide a clinical and scientific framework to increase the validity of apathy as a clinical construct. This should also help to pave the path for apathy in brain disorders to be an interventional target. CoBTeK IA Memory Centre University Cote d'Azur Sunnybrook Research Institute and Departments of Pharmacology/Toxicology and Psychiatry University of Toronto Department of Psychiatry Instituto de Investigación Sanitaria (imas12) Hospital Universitario 12 de Octubre & Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM) School for Mental Health and Neuroscience Alzheimer Center Limburg STARS team - INRIA Sophia Antipolis Department of Psychiatry and Psychotherapy Innsbruck Medical University Regional Resource Centre of Old Age Psychiatry Paris Descartes University, Assistance Publique-Hôpitaux de Paris, Corentin-Celton Hospital Memory Center CMRR CHU – CoBTeK lab University Cote d'Azur Centre des Maladies Cognitives et Comportementales (IM2A) Institut du Cerveau et de la Moelle épinière (ICM) UMR-S975 AP-HP Salpêtrière Hospital Sorbonne University Neurology and Movement Disorders Lille University Medical Center Inserm U1171 Nuffield Department of Clinical Neurosciences (John Radcliffe Hospital Oxford OX3 9DU) & Department of Experimental Psychology University of Oxford AP-HP Neurology deparment Salpetriere hospital Inserm U 1127 CNRS UMR 7225 Sorbonne Universités UPMC Univ Paris 06 UMR S 1127 Institut du Cerveau et de la Moelle épinière ICM FRONTlab School of medicine Sorbonne Universités Agenzia Italiana del Farmaco, via del Tritone 181 Clinical Research Neurology Lundbeck SAS Bracket, Wayne moebius-consult GmbH psi-napse EA4712 “Comportement et noyaux gris centraux” Université de Rennes 1 Laboratorio de Neurociencias LIM27 Departamento e Instituto de Psiquiatria Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de Sao Paulo UNESP - Univ Estadual Paulista Biosciences Institute, Campus of Rio Claro Department of Psychiatry and Behavioral Sciences Stanford University School of Medicine Stanford University Laboratorio de Neurociencias LIM27 Departamento e Instituto de Psiquiatria Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de Sao Paulo UNESP - Univ Estadual Paulista Biosciences Institute, Campus of Rio Claro

Published
2018
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6. Identification and validation of biomarkers for autism spectrum disorders

Author

Loth, E., Spooren, W., Ham, L.M., Isaac, M.B., Auriche-Benichou, C., Banaschewski, T., Baron-Cohen, S., Broich, K., Bolte, S., Bourgeron, T., Charman, T., Collier, D., Andres-Trelles, F. de, Durston, S., Ecker, C., Elferink, A., Haberkamp, M., Hemmings, R., Johnson, M.H., Jones, E.J.H., Khwaja, O.S., Lenton, S., Mason, L., Mantua, V., Meyer-Lindenberg, A., Lombardo, M.V., O'Dwyer, L., Okamoto, K., Pandina, G.J., Pani, L., Persico, A.M., Simonoff, E., Tauscher-Wisniewski, S., Llinares-Garcia, J., Vamvakas, S., Williams, S., Buitelaar, J.K., Murphy, D.G.M., Loth, E., Spooren, W., Ham, L.M., Isaac, M.B., Auriche-Benichou, C., Banaschewski, T., Baron-Cohen, S., Broich, K., Bolte, S., Bourgeron, T., Charman, T., Collier, D., Andres-Trelles, F. de, Durston, S., Ecker, C., Elferink, A., Haberkamp, M., Hemmings, R., Johnson, M.H., Jones, E.J.H., Khwaja, O.S., Lenton, S., Mason, L., Mantua, V., Meyer-Lindenberg, A., Lombardo, M.V., O'Dwyer, L., Okamoto, K., Pandina, G.J., Pani, L., Persico, A.M., Simonoff, E., Tauscher-Wisniewski, S., Llinares-Garcia, J., Vamvakas, S., Williams, S., Buitelaar, J.K., and Murphy, D.G.M.

Abstract

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Published
2015

7. Clinical trials and late-stage drug development for Alzheimer's disease : an appraisal from 1984 to 2014

Author

Schneider, L. S., Mangialasche, F., Andreasen, N., Feldman, H., Giacobini, E., Jones, R., Mantua, V., Mecocci, P., Pani, L., Winblad, B., Kivipelto, M., Schneider, L. S., Mangialasche, F., Andreasen, N., Feldman, H., Giacobini, E., Jones, R., Mantua, V., Mecocci, P., Pani, L., Winblad, B., and Kivipelto, M.

Abstract

The modern era of drug development for Alzheimer's disease began with the proposal of the cholinergic hypothesis of memory impairment and the 1984 research criteria for Alzheimer's disease. Since then, despite the evaluation of numerous potential treatments in clinical trials, only four cholinesterase inhibitors and memantine have shown sufficient safety and efficacy to allow marketing approval at an international level. Although this is probably because the other drugs tested were ineffective, inadequate clinical development methods have also been blamed for the failures. Here, we review the development of treatments for Alzheimer's disease during the past 30years, considering the drugs, potential targets, late-stage clinical trials, development methods, emerging use of biomarkers and evolution of regulatory considerations in order to summarize advances and anticipate future developments. We have considered late-stage Alzheimer's disease drug development from 1984 to 2013, including individual clinical trials, systematic and qualitative reviews, meta-analyses, methods, commentaries, position papers and guidelines. We then review the evolution of drugs in late clinical development, methods, biomarkers and regulatory issues. Although a range of small molecules and biological products against many targets have been investigated in clinical trials, the predominant drug targets have been the cholinergic system and the amyloid cascade. Trial methods have evolved incrementally: inclusion criteria have largely remained focused on mild-to-moderate Alzheimer's disease criteria, recently extending to early or prodromal Alzheimer disease or mild cognitive impairment due to Alzheimer's disease', for drugs considered to be disease modifying. The duration of trials has remained at 6-12months for drugs intended to improve symptoms; 18- to 24-month trials have been established for drugs expected to attenuate clinical course. Cognitive performance, activities of daily living, global, AuthorCount:11

Published
2014
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8. Does psychomotor retardation define a clinically relevant phenotype of unipolar depression?

Author

Paola Rucci, A. Litta, Mario Miniati, A. Benvenuti, Valentina Mantua, V. Lombardi, Andrea Fagiolini, Lorenzo Lattanzi, E. Frank, S. Calugi, G.B. Cassano, Calugi S., Cassano GB., Litta A., Rucci P., Benvenuti A., Miniati M., Lattanzi L., Mantua V., Lombardi V., Fagiolini A., and Frank E.

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, phenotype, behavioral disciplines and activities, Statistics, Nonparametric, Article, Young Adult, mental disorders, medicine, Major depression, Phenotype, Retardation, Humans, Bipolar disorder, Age of Onset, Psychiatry, Depression (differential diagnoses), Aged, Psychiatric Status Rating Scales, Depressive Disorder, Major, Chi-Square Distribution, Psychomotor retardation, BIPOLAR DISORDER, Middle Aged, medicine.disease, Psychiatry and Mental health, Clinical Psychology, Logistic Models, Mood, ROC Curve, Major depressive disorder, Female, Psychomotor Disorders, Age of onset, medicine.symptom, Psychomotor disorder, Psychology, Psychopathology
Abstract

Background The recognition and assessment of psychomotor retardation may have implications for better definition of the clinical phenotypes of depression. The aim of this study was to assess the clinical correlates of psychomotor retardation endorsed at any time during the patients' lifetime (LPR). Methods The study sample included 291 patients with non-psychotic major depressive disorder (MDD) participating in the clinical trial, “Depression: The Search for Treatment-Relevant Phenotypes.” Psychomotor retardation was measured using a factor derived from the Mood Spectrum Self-Report (MOODS-SR) assessment. Using a pre-defined cut-off score on the lifetime psychomotor retardation (LPR) factor of the MOODS-SR, participants were classified into high and low scorers. Logistic regression analysis was used to evaluate the relationship between LPR and subthreshold bipolarity. Results Compared to low scorers, participants with high scores on the LPR factor had greater severity of depression and more bipolarity indicators. Conclusions The MOODS-SR appears to be helpful to identify clinical phenotypes of unipolar depression and to highlight the usefulness of a lifetime approach to the assessment of psychopathology in the characterisation of patients with unipolar depression.

Published
2011

9. Manic episode after ventricular-peritoneal shunt replacement in a patient with radiation-induced hydrocephalus: the role of lifetime subthreshold bipolar features.

Author

Callari A, Mantua V, Miniati M, Benvenuti A, Mauri M, and Dell'osso L

Abstract

We present a case report of a woman hospitalized for a ventricular-peritoneal shunting replacement, who developed a manic episode with psychotic symptoms after hydrocephalus resolution. We have no knowledge of cases of manic episodes due to hydrocephalus resolution by ventricular-peritoneal shunt replacement, although previous case reports have suggested that hydrocephalus might induce rapid-onset affective episodes or mood cycles. The patient's history revealed the lifetime presence of signs and features belonging to the subthreshold bipolar spectrum, in absence of previous full-blown episodes of a bipolar disorder. Our hypothesis is that such lifetime sub-threshold bipolar features represented precursors of the subsequent full-blown manic episode, triggered by an upregulated binding of striatum D2 receptors after the ventricular-peritoneal shunt replacement.

Published
2014
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11. Volume, neuron density and total neuron number in five subcortical regions in schizophrenia.

Author

Kreczmanski P, Heinsen H, Mantua V, Woltersdorf F, Masson T, Ulfig N, Schmidt-Kastner R, Korr H, Steinbusch HW, Hof PR, and Schmitz C

Subjects
Adult, Amygdala pathology, Cadaver, Caudate Nucleus pathology, Cell Count, Humans, Male, Mediodorsal Thalamic Nucleus pathology, Middle Aged, Nucleus Accumbens pathology, Putamen pathology, Time Factors, Neurons pathology, Prosencephalon pathology, Schizophrenia pathology
Abstract

Several studies have pointed to alterations in mean volumes, neuron densities and total neuron numbers in the caudate nucleus (CN), putamen, nucleus accumbens (NA), mediodorsal nucleus of the thalamus (MDNT) and lateral nucleus of the amygdala (LNA) in schizophrenia. However, the results of these studies are conflicting and no clear pattern of alterations has yet been established in these subcortical regions, possibly due to differences in quantitative histological methods used as well as differences in the investigated case series. The present study investigates these subcortical regions in both hemispheres of the same post-mortem brains for volume, neuron density and total neuron number with high-precision design-based stereology. The analysed case series consisted of 13 post-mortem brains from male schizophrenic patients [age range: 22-64 years; mean age 51.5 +/- 3.3 years (mean +/- SEM)] and 13 age-matched male controls (age range: 25-65 years; mean age 51.9 +/- 3.1 years). A general linear model multivariate analysis of variance with diagnosis and hemisphere as fixed factors and illness duration (schizophrenic patients) or age (controls), post-mortem interval and fixation time as covariates showed a number of statistically significant alterations in the brains from schizophrenic patients compared with the controls. There was a reduced mean volume of the putamen [-5.0% on the left side (l) and -4.1% on the right side (r)] and the LNA (l: -12.1%, r: -17.6%), and a reduced mean total neuron number in the CN (l: -10.4%, r: -10.2%), putamen (l: -8.1%, r: -11.6%) and the LNA (l: -15.9%, r: -16.2%). These data show a previously unreported, distinct pattern of alterations in mean total neuron numbers in identified subcortical brain regions in a carefully selected sample of brains from schizophrenic patients. The rigorous quantitative analysis of several regions in brains from schizophrenic patients and matched controls is crucial to provide reliable information on the neuropathology of schizophrenia as well as insights about its pathogenesis.

Published
2007
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