Background: Consensus guidance for the development and identification of high-quality Alzheimer's disease clinical trials is needed for protocol development and conduct of clinical trials. Methods: An ad hoc consensus committee was convened in conjunction with the Alzheimer's Association to develop consensus recommendations. Results: Consensus was readily reached for the need to provide scientific justification, registration of trials, institutional review board oversight, conflict of interest disclosure, funding source disclosure, defined trial population, recruitment resources, definition of the intervention, specification of trial duration, appropriate payment for participant engagement, risk-benefit disclosure as part of the consent process, and the requirement to disseminate and/or publish trial results even if the study is negative. Conclusions: This consensus guidance should prove useful for the protocol development and conduct of clinical trials, and may further provide a platform for the development of education materials that may help guide appropriate clinical trial participation decisions for potential trial participants and the general public.
|Number of pages
|Alzheimer's and Dementia
|Published - Jun 2022
Bibliographical noteFunding Information:
The authors wish to acknowledge Laurie Ryan, PhD, of the National Institute on Aging program, and Ira Goldman, MD, from the Compass Clinic in Orlando, FL, for their key contributions in leadership and scientific guidance on this project. This manuscript was facilitated by the Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment (ISTAART), through the Clinical Trials Advancement and Methods Professional Interest Area (PIA). The views and opinions expressed by authors in this publication represent those of the authors and do not necessarily reflect those of the PIA membership, ISTAART, or the Alzheimer's Association.
Greg A. Jicha has received contract research support from AbbVie, Biohaven, Eisai, Lilly, and at time of submission is the immediate past chair for the Clinical Trials & Methodology Professional Interest Area Chair for the Alzheimer's Association, and the Chair for the Clinical Measures & Diagnosis working group for the NIH/NIA ADRC NACC Clinical Task force. Erin L. Abner has no disclosures. Steven E. Arnold has received grant funding from the NIH, Alzheimer's Drug Discovery Foundation, Alzheimer's Association, Amylyx, Seer Biosciences, Target ALS Foundation, Abbvie, Merck, EIP Pharma, Janssen/Johnson & Johnson, and Novartis; has received consulting fees from vTv and Cassava; has received consulting fees from Eisai, Biogen, Abbvie; has participated on a Data Safety Monitoring Board or Advisory Board for Cortexyme; and has held a leadership role with Bob's Last Marathon. Maria C. Carrillo has participated on a Data Safety Monitoring Board or Advisory Board for US Pointer, and has held a leadership position with the Easterseals Board of Directors. Hiroko H. Dodge has received grants or contracts from P30AG024978, U2CAG054397, R01AG056712, R01AG0380651, R21AG062679, P30 AG053760, U01NS100611, U2CAG057441, U01NS106670, R01AG054484; has received payment or honoraria from Alzheimer's Clinical Trials Consortium (ACTC), Florida 1 ADC, Northwestern University, Einstein School of Medicine; has participated on a Data Safety Monitoring Board or Advisory Board for Wake Forest University US POINTER study, University of Alabama RAATE (Reducing African Americans’ Alzheimer's Disease Risk Through Exercise), Wake Forest BEST‐AD, Wake Forest Progression of Alzheimer's Disease; and has held a leadership role Clinical Trials Methods Professional Interests Area (PIA): founding chair (2015 to 2018) Unpaid position. Steven D. Edland has participated on a Data Safety Monitoring Board or Advisory Board for Johnson & Johnson, and from Eli Lilly. Keith N. Fargo has received consulting fees from Gerson Lehrman Group; has received travel support through the Alzheimer's Association; has participated on a Data Safety Monitoring Board or Advisory Board for Alzheimer's Clinical Trials Consortium (ACTC), the Research Participant Advisory Board (RPAB) and the Inclusion, Diversity, and Education in Alzheimer's Disease Clinical Trials (IDEA‐CT) Committee; and has held leadership positions with the Alzheimer's Association (Director of Scientific Programs & Outreach) and CMT Research Foundation—Chief Scientific Officer. Howard H. Feldman has received grants or contracts from ADCS Clinical Trials grant funding: Annovis (Posiphen), Biohaven (BH 4157), Vivoryon (PQ 912), AC Immune (ACI‐24‐1301), LuMind (ADC‐059‐LIFE‐DSR); royalties or licenses from Royalty payment received for Feldman HH (filed November 26, 2008), Detecting and Treating Dementia Serial Number 12/3‐2691 U.S. Patent No. PCT/US2007/07008. Washington, DC: U.S. Patent and Trademark Office; consulting fees from Eisai Pharmaceuticals, Merck Pharmaceuticals, Arkuda Therapeutics, Axon Neuroscience, Banner Health, Samumed, Samus Therapeutics, Tau Consortium, and Novo Nordisk; travel support from ADDF, Samus, Samumed, Axon, and Novo Nordisk; has participated on a Data Safety Monitoring Board or Advisory Board for Roche/Genentech Pharmaceuticals (DSMB and DMC) and Janssen Research & Development LLC (DSMB). Larry B. Goldstein has received grants or contracts from NIH, consulting fees from Abbott, payment or honoraria from University of South Florida, travel support from American Academy of Neurology, and has held a leadership role for American Academy of Neurology Joint Audit Committee. James Hendrix has received consulting fees from Gerson Lehrman Group; and has patents planned, issued, or pending for US 20190345115. Ruth Peters has received grants or contracts from Grants from Australian National Health and Medical Research Council, the Australian Medical Health Futures Fund, and the University of New South Wales Ageing Futures Institute; and has held a leadership roles as vice chair and chair for the Alzheimer's Association ISAART clinical trials and methodology professional interest area. Julie M. Robillard has received grants or contracts from AGE‐WELL, Canadian Consortium on Neurodegeneration in Aging, Alzheimer Society of British Columbia, Social Sciences and Humanities Research Council of Canada, Michael Smith Foundation for Health Research, BC SUPPORT Unit, BC Children's Hospital Research Institute, and has held a leadership roles as Chair, Ethical, Legal, Social Implications Cross‐cutting Program of the Canadian Consortium on Neurodegeneration in Aging, Lead, Ethics and Practice, AGE‐WELL, Vice‐chair, Technology and Dementia Executive Committee, ISTAART PIA, Member, Board of Directors, Medical Device Development Centre of BC. Lon S. Schneider has received support, grants, or contracts from NIH P30 AG066530, USC Alzheimer Disease Research Center (ADRC), Eisai, Eli Lilly, Roche/Genentech, Biogen, Biohaven, Novartis, and Washington University/ NIA DIAN‐TU; consulting fees from Abbott, AC Immune, Avraham, Ltd, Boehringer Ingelheim, Cognition Therapeutics, Cortexyme, Eisai, FujiFilm, Immunobrain Checkpoint Ltd, Neurally Inc, Neurim Ltd, Neuronix Ltd, Samus, Takeda, vTv; and has participated on a Data Safety Monitoring Board or Advisory Board for Abbott, AC Immune, Avraham, Ltd, Boehringer Ingelheim, Cognition Therapeutics, Cortexyme, Eisai, FujiFilm, Immunobrain Checkpoint Ltd, Neurally Inc, Neurim Ltd, Neuronix Ltd, Samus, Takeda, vTv. Maria C. Carrillo, Jodi R. Titiner, and Christopher J. Weber are full‐time employees of the Alzheimer's Association.
© 2021 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
- Alzheimer's disease
- clinical trial
ASJC Scopus subject areas
- Health Policy
- Developmental Neuroscience
- Clinical Neurology
- Geriatrics and Gerontology
- Cellular and Molecular Neuroscience
- Psychiatry and Mental health