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3. Clinical Meaningfulness in Alzheimer’s Disease Clinical Trials. A Report from the EU-US CTAD Task Force

Author

Angioni, D., Cummings, J., Lansdall, C. J., Middleton, L., Sampaio, C., Gauthier, S., Cohen, S., Petersen, R. C., Rentz, D. M., Wessels, A. M., Hendrix, S. B., Jessen, F., Carrillo, M. C., Doody, R. S., Irizarry, M., Andrews, J. S., Vellas, B., Aisen, P., Andrieu, Sandrine, Bateman, Randall, Batrla, Richard, Bell, Joanne, Bosson, Oskar, Bozeat, Sasha, Brooks, Dawn, Haeberlein, Samantha Budd, Buracchio, Teresa, Cho, Min, Choung, Matthew, Cook, Gavin, Crisitello, Darrin, Dangond, Fernando, de Santi, Susan, Dennehy, Ellen, Dhadda, Shobha, Dhillon, Harjeet, Dunn, Billy, Egan, Michael, Elwood, Fiona, Eriksson, Sven, Fagan, Tom, Fillit, Howard, Freskgard, Per-Ola, Gallagher, Diana, Gangi, Gopi, Granda, Carlos, Greeley, David, Gronblad, Anna-Kaija, Hampel, Harald, Hawthorne, Paul, Henley, David, Herring, Joe, Hersch, Steve, Holt, Bill, Iwatsubo, Takeshi, Jones, Daryl, Kahl, Anja, Kinney, Gene, Kolb, Hartmuth, Kramer, Lynn, Kulic, Luka, Kumar, Sanjay, Lannfelt, Lars, Lawson, John, Legrand, Valérie, Lenington, Rachel, Longo, Frank, Matthews, Brandy, Masterman, Donna, McLinden, Kristina, Mikels, Sarah, Miller, Michael, Mintun, Mark, Moebius, Hans, Monteiro, Cecilia, Morken, Mario, Murphy, Jennifer, Odergren, Tomas, Osswald, Gunilla, Parnas, Laura, Patru, Maria-Magdalena, Prazma, Charlene, Raman, Rema, Reyderman, Larisa, Rogers, Sharon, Roman, Lise, Romano, Gary, Roskey, Mark, Rubino, Ivana, Ryan, Laurie, Salloway, Stephen, Schindler, Rachel, Schneider, Lon, Scott, David, Sims, John, Skovronsky, Daniel, Soto, Marion, Sperling, Reisa, Steukers, Lennert, Stoops, Erik, Strittmatter, Stephen, Tahami, Amir, Tamagnan, Gilles, Tariot, Gilles, Toloue, Masoud, Touchon, Jacques, Vanmechelen, Eugeen, Walt, Len, Weinberg, Mark, Weiner, Michael, White, Anne, Wiesel, Iris, Wilson, David, Yarenis, Lisa, Zago, Wagner, and Zhou, Jin

Published
2024
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5. Lecanemab: Appropriate Use Recommendations

Author

Cummings, J, Apostolova, L, Rabinovici, GD, Atri, A, Aisen, P, Greenberg, S, Hendrix, S, Selkoe, D, Weiner, M, Petersen, RC, and Salloway, S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Alzheimer's Disease, Neurodegenerative, Neurosciences, Aging, Brain Disorders, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Patient Safety, Clinical Trials and Supportive Activities, Biotechnology, Dementia, Clinical Research, Acquired Cognitive Impairment, Prevention, Neurological, Humans, Apolipoprotein E4, Alzheimer Disease, Antibodies, Monoclonal, Amyloid, Alzheimer’s disease, Food and Drug Administration, accelerated approval, aducanumab, amyloid imaging, amyloid-related imaging abnormalities, donanemab, lecanemab, magnetic resonance imaging, prescribing information, Biological psychology, Cognitive and computational psychology
Abstract

Lecanemab (Leqembi®) is approved in the United States for the treatment of Alzheimer's disease (AD) to be initiated in early AD (mild cognitive impairment [MCI] due to AD or mild AD dementia) with confirmed brain amyloid pathology. Appropriate Use Recommendations (AURs) are intended to help guide the introduction of new therapies into real-world clinical practice. Community dwelling patients with AD differ from those participating in clinical trials. Administration of lecanemab at clinical trial sites by individuals experienced with monoclonal antibody therapy also differs from the community clinic-based administration of lecanemab. These AURs use clinical trial data as well as research and care information regarding AD to help clinicians administer lecanemab with optimal safety and opportunity for effectiveness. Safety and efficacy of lecanemab are known only for patients like those participating in the phase 2 and phase 3 lecanemab trials, and these AURs adhere closely to the inclusion and exclusion criteria of the trials. Adverse events may occur with lecanemab including amyloid related imaging abnormalities (ARIA) and infusion reactions. Monitoring guidelines for these events are detailed in this AUR. Most ARIA with lecanemab is asymptomatic, but a few cases are serious or, very rarely, fatal. Microhemorrhages and rare macrohemorrhages may occur in patients receiving lecanemab. Anticoagulation increases the risk of hemorrhage, and the AUR recommends that patients requiring anticoagulants not receive lecanemab until more data regarding this interaction are available. Patients who are apolipoprotein E ε4 (APOE4) gene carriers, especially APOE4 homozygotes, are at higher risk for ARIA, and the AUR recommends APOE genotyping to better inform risk discussions with patients who are lecanemab candidates. Clinician and institutional preparedness are mandatory for use of lecanemab, and protocols for management of serious events should be developed and implemented. Communication between clinicians and therapy candidates or those on therapy is a key element of good clinical practice for the use of lecanemab. Patients and their care partners must understand the potential benefits, the potential harms, and the monitoring requirements for treatment with this agent. Culture-specific communication and building of trust between clinicians and patients are the foundation for successful use of lecanemab.

Published
2023

7. Aducanumab: Appropriate Use Recommendations Update

Author

Cummings, Jeffrey, Rabinovici, GD, Atri, A, Aisen, P, Apostolova, LG, Hendrix, S, Sabbagh, M, Selkoe, D, Weiner, M, and Salloway, S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Neurosciences, Aging, Alzheimer's Disease, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Brain Disorders, Clinical Research, Dementia, Neurodegenerative, Acquired Cognitive Impairment, Neurological, Alzheimer Disease, Amyloid, Antibodies, Monoclonal, Humanized, Apolipoprotein E4, Humans, United States, Alzheimer's disease, aducanumab, Aduhelm, appropriate use, titration, ARIA, amyloid imaging, MRI, Biological psychology, Cognitive and computational psychology
Abstract

Aducanumab (Aduhelm) is approved in the United States for the treatment of patients with mild cognitive impairment due to Alzheimer's disease or mild AD dementia. Aducanumab Appropriate Use Recommendations (AURs) have been published and have helped guide best practices for use of aducanumab. As real-world use has occurred and more information has accrued, the AURs require refinement. We update the AURs to better inform appropriate patient selection and improve shared decision-making, safety monitoring, and risk mitigation in treated patients. Based on evolving experience we emphasize the importance of detecting past medical conditions that may predispose to amyloid related imaging abnormalities (ARIA) or may increase the likelihood of ARIA complications including autoimmune or inflammatory conditions, seizures, or disorders associated with extensive white matter pathology. The apolipoprotein E ε4 (APOE4) genotype is strongly associated with ARIA and exhibits a gene dose effect. We recommend that clinicians perform APOE genotyping to better inform patient care decisions, discussions regarding risk, and clinician vigilance concerning ARIA. As most ARIA occurs during the titration period of aducanumab, we suggest performing MRI before the 5th, 7th, 9th, and 12th infusions to improve detection. Uncommonly, ARIA may be recurrent or serious; we suggest additional parameters for treatment discontinuation taking these observations into account. It is important to continue to learn from the real-world use of aducanumab and the AURs will continue to evolve as new information becomes available. This AUR update does not address efficacy, price, or insurance coverage and is provided to assist clinicians to establish best practices for use of aducanumab in the treatment of patients with mild cognitive impairment and mild Alzheimer's dementia.

Published
2022

10. Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER

Author

Abraham-Pratt, I., Ali, L., Armstrong, S., Binns, H., Brubaker, J., Cristison, A., Fox, C., Gordon, C., Hendrix, S., Hes, D., Jenkins, L., Joseph, M., Heyrman, M., Liu, L., McClure, A., Hofley, M., Negrete, S., Novick, M., O'Hara, V., Rodrue, J., Santos, M., Stoll, J., Stratbucker, W., Sweeney, B., Tester, J., Walka, S., deHeer, H., Wallace, S., Walsh, S., Wittcopp, C., Weedn, A., Yee, J., Grace, B., Kumar, Seema, King, Eileen C., Christison, Amy L., Kelly, Aaron S., Ariza, Adolfo J., Borzutzky, Claudia, Cuda, Suzanne, and Kirk, Shelley

Published
2019
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22. Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD

Author

Dyer, A. H., Murphy, C., Lawlor, B., Kennelly, S. P., Segurado, R., Olde Rikkert, M. G. M., Howard, R., Pasquier, F., Börjesson-Hanson, A., Tsolaki, M., Lucca, U., Molloy, D. William, Coen, R., Riepe, M. W., Kálmán, J., Kenny, R. A., Cregg, F., O'Dwyer, S., Walsh, C., Adams, J., Banzi, R., Breuilh, L., Daly, L., Hendrix, S., Aisen, P., Gaynor, S., Sheikhi, A., Taekema, D. G., Verhey, F. R., Nemni, R., Nobili, F., Franceschi, M., Frisoni, G., Zanetti, O., Konsta, A., Anastasios, O., Nenopoulou, S., Tsolaki-Tagaraki, F., Pakaski, M., Dereeper, O., Sayette, V. D. L., Sénéchal, O., Lavenu, I., Devendeville, A., Calais, G., Crawford, F., Mullan, M., Aalten, P., Berglund, M. A., Claassen, J. A., De Heus, R. A., De Jong, D. L. K., Godefroy, O., Hutchinson, S., Ioannou, A., Jonsson, M., Kent, A., Kern, J., Nemtsas, P., Panidou, M.-K., Abdullah, L., Paris, D., Santoso, A. M., van Spijker, G. J., Spiliotou, M., Thomoglou, G., Wallin, A., and NILVAD Study Group

Subjects
medicine.medical_specialty, Alzheimer disease, Cognition, Dementia, Falls, Alzheimer`s disease Donders Center for Medical Neuroscience [Radboudumc 1], medicine.medical_treatment, Falls in older adults, lcsh:Geriatrics, 03 medical and health sciences, 0302 clinical medicine, Physical medicine and rehabilitation, medicine, Humans, Cognitive Dysfunction, 030212 general & internal medicine, Gait, Aged, Rehabilitation, business.industry, medicine.disease, Gait speed, Walking Speed, lcsh:RC952-954.6, Cross-Sectional Studies, Cohort, Accidental Falls, Geriatrics and Gerontology, Alzheimer's disease, business, human activities, 030217 neurology & neurosurgery, Research Article
Abstract

Background Previous evidence suggests that slower gait speed is longitudinally associated with cognitive impairment, dementia and falls in older adults. Despite this, the longitudinal relationship between gait speed, cognition and falls in those with a diagnosis of dementia remains poorly explored. We sought to assess this longitudinal relationship in a cohort of older adults with mild to-moderate Alzheimer Disease (AD). Methods Analysis of data from NILVAD, an 18-month randomised-controlled trial of Nilvadipine in mild to moderate AD. We examined: (i) the cross-sectional (baseline) association between slow gait speed and cognitive function, (ii) the relationship between baseline slow gait speed and cognitive function at 18 months (Alzheimer Disease Assessment Scale, Cognitive Subsection: ADAS-Cog), (iii) the relationship between baseline cognitive function and incident slow gait speed at 18 months and finally (iv) the relationship of baseline slow gait speed and incident falls over the study period. Results Overall, one-tenth (10.03%, N = 37/369) of participants with mild-to-moderate AD met criteria for slow gait speed at baseline and a further 14.09% (N = 52/369) developed incident slow gait speed at 18 months. At baseline, there was a significant association between poorer cognition and slow gait speed (OR 1.05, 95% CI 1.01–1.09, p = 0.025). Whilst there was no association between baseline slow gait speed and change in ADAS-Cog score at 18 months, a greater cognitive severity at baseline predicted incident slow gait speed over 18 months (OR 1.04, 1.01–1.08, p = 0.011). Further, slow gait speed at baseline was associated with a significant risk of incident falls over the study period, which persisted after covariate adjustment (IRR 3.48, 2.05–5.92, p Conclusions Poorer baseline cognition was associated with both baseline and incident slow gait speed. Slow gait speed was associated with a significantly increased risk of falls over the study period. Our study adds further evidence to the complex relationship between gait and cognition in this vulnerable group and highlights increased falls risk in older adults with AD and slow gait speed. Trial registration Secondary analysis of the NILVAD trial (Clincaltrials.gov NCT02017340; EudraCT number 2012–002764-27). First registered: 20/12/2013.

Published
2020

38. Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER

Author

Kumar, Seema, primary, King, Eileen C., additional, Christison, Amy L., additional, Kelly, Aaron S., additional, Ariza, Adolfo J., additional, Borzutzky, Claudia, additional, Cuda, Suzanne, additional, Kirk, Shelley, additional, Abraham-Pratt, I., additional, Ali, L., additional, Armstrong, S., additional, Binns, H., additional, Brubaker, J., additional, Cristison, A., additional, Fox, C., additional, Gordon, C., additional, Hendrix, S., additional, Hes, D., additional, Jenkins, L., additional, Joseph, M., additional, Heyrman, M., additional, Liu, L., additional, McClure, A., additional, Hofley, M., additional, Negrete, S., additional, Novick, M., additional, O'Hara, V., additional, Rodrue, J., additional, Santos, M., additional, Stoll, J., additional, Stratbucker, W., additional, Sweeney, B., additional, Tester, J., additional, Walka, S., additional, deHeer, H., additional, Wallace, S., additional, Walsh, S., additional, Wittcopp, C., additional, Weedn, A., additional, Yee, J., additional, and Grace, B., additional

Published
2019
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39. Molecular and cellular aspects of contaminant toxicity in plants: The importance of sulphur and associated signalling pathways

Author

Hendrix, S., Schröder, P., Keunen, E., Huber, C., and Cuypers, A.

Subjects
Cysteine, Detoxification, Glutathione, Metals, Methionine, Organics, Plant Stress, Sam, Signalling, Sulphur
Abstract

Environmental contamination with metals and organic compounds poses a serious threat to human health. Investigating plant responses to these contaminants at the molecular and cellular level is crucial to optimize phytoremediation strategies to clean up contaminated soils. Two key players in plant stress responses are the sulphur-containing amino acids cysteine and methionine. Cysteine is an important constituent of the metal-chelating metallothioneins and is also the precursor for glutathione and subsequent phytochelatin synthesis. During stress conditions, glutathione is involved in (1) metal chelation, (2) xenobiotic detoxification and (3) antioxidative defence. The activated form of methionine, S-adenosylmethionine, is involved in the synthesis of ethylene and polyamines, both playing important roles in signal transduction. This review provides an overview of sulphur uptake and assimilation and its conversion into basic metabolites essential for detoxification and signal transduction during metal and organic contaminant exposure in plants. Furthermore, the cross talk between these pathways and their relation to the contaminant-induced oxidative challenge are discussed.

Published
2017

40. EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials

Author

Aisen, P., Touchon, J., Amariglio, R, Andrieu, S., Bateman, R., Breitner, J., Donohue, M, Dunn, B, Doody, R, Fox, N, Gauthier, S., Grundman, M, Hendrix, S, Ho, C, Isaac, M, Raman, R, Rosenberg, P, Schindler, R, Schneider, L, Sperling, R, Tariot, P, Weiner, M., Welsh-Bohmer, K., Vellas, B., Task Force, EU/US/CTAD, Neuropsychiatrie : recherche épidémiologique et clinique (PSNREC), Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'épidémiologie [Toulouse], CHU Toulouse [Toulouse], and Université Montpellier 1 (UM1)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
medicine.medical_specialty, cognitive outcome measures, mild behavioral impairment, media_common.quotation_subject, [SDV]Life Sciences [q-bio], Advisory Committees, Applied psychology, education, Alternative medicine, Disease, secondary prevention trials, informant-reported outcome measures, Article, 03 medical and health sciences, 0302 clinical medicine, Alzheimer Disease, Cognitive change, Outcome Assessment, Health Care, Humans, Medicine, European Union, Function (engineering), Nootropic Agents, patient-reported outcome measures, 030304 developmental biology, media_common, Clinical Trials as Topic, 0303 health sciences, clinical trials, Task force, Management science, business.industry, Cognition, molecular imaging, United States, 3. Good health, Clinical trial, cognitive composites, Prevention trials, business, Alzheimer’s disease, 030217 neurology & neurosurgery
Abstract

International audience; At a meeting of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force in December 2016, an international group of investigators from industry, academia, and regulatory agencies reviewed lessons learned from ongoing and planned prevention trials, which will help guide future clinical trials of AD treatments, particularly in the pre-clinical space. The Task Force discussed challenges that need to be addressed across all aspects of clinical trials, calling for innovation in recruitment and retention, infrastructure development, and the selection of outcome measures. While cognitive change provides a marker of disease progression across the disease continuum, there remains a need to identify the optimal assessment tools that provide clinically meaningful endpoints. Patient- and informant-reported assessments of cognition and function may be useful but present additional challenges. Imaging and other biomarkers are also essential to maximize the efficiency of and the information learned from clinical trials.

Published
2017

41. Exploratory analyses suggest less cognitive decline with nilvadipine treatment in very mild Alzheimer’s disease subjects

Author

Abdullah, L, primary, Crawford, F, additional, Langlois, H, additional, Tsolaki, M, additional, Börjesson-Hanson, A, additional, Olde Rikkert, M, additional, Pasquier, F, additional, Wallin, A, additional, Kennelly, S, additional, Hendrix, S, additional, Blennow, K, additional, Lawlor, B, additional, and Mullan, M, additional

Published
2018
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45. Parents in academia: New norms required

Author

van Engen, M.L., Beijer, Susanne, Herschberg, C., Bleijenbergh, I., Vinkenburg, C.J., Hendrix, S., Management and Organisation, Sociology [until 2010], Amsterdam Business Research Institute, and Department of Human Resource Studies

Subjects
ComputingMilieux_LEGALASPECTSOFCOMPUTING
Published
2015

47. Facing the changes.

Author

Plourde J, Richards C, Vectirelis D, D'Antuono E, Siren S, and Hendrix S

Published
2002

49. REGISTRIES AND COHORTS TO ACCELERATE EARLY PHASE ALZHEIMER’S TRIALS. A REPORT FROM THE E.U./U.S. CLINICAL TRIALS IN ALZHEIMER’S DISEASE TASK FORCE

Author

Aisen, P., primary, Touchon, J., additional, Andrieu, S., additional, Boada, M., additional, Doody, R., additional, Nosheny, R.L., additional, Langbaum, J.B., additional, Schneider, L., additional, Hendrix, S., additional, Wilcock, G., additional, Molinuevo, J.L., additional, Ritchie, C., additional, Ousset, P.-J., additional, Cummings, J., additional, Sperling, R., additional, DeKosky, S.T., additional, Lovestone, S., additional, Hampel, H., additional, Petersen, R., additional, Legrand, V., additional, Egan, M., additional, Randolph, C., additional, Salloway, S., additional, Weiner, M., additional, and Vellas, B., additional

Published
2016
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