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Observational Study
. 2016 May;12(5):614-22.
doi: 10.1016/j.jalz.2016.01.009. Epub 2016 Mar 15.

Ethical challenges in preclinical Alzheimer's disease observational studies and trials: Results of the Barcelona summit

José L Molinuevo  1 , Jordi Cami  2 , Xavier Carné  3 , Maria C Carrillo  4 , Jean Georges  5 , Maria B Isaac  6 , Zaven Khachaturian  7 , Scott Y H Kim  8 , John C Morris  9 , Florence Pasquier  10 , Craig Ritchie  11 , Reisa Sperling  12 , Jason Karlawish  13
Affiliations
Observational Study

Ethical challenges in preclinical Alzheimer's disease observational studies and trials: Results of the Barcelona summit

José L Molinuevo et al. Alzheimers Dement. 2016 May.

Abstract

Alzheimer's disease (AD) is among the most significant health care burdens. Disappointing results from clinical trials in late-stage AD persons combined with hopeful results from trials in persons with early-stage suggest that research in the preclinical stage of AD is necessary to define an optimal therapeutic success window. We review the justification for conducting trials in the preclinical stage and highlight novel ethical challenges that arise and are related to determining appropriate risk-benefit ratios and disclosing individuals' biomarker status. We propose that to conduct clinical trials with these participants, we need to improve public understanding of AD using unified vocabulary, resolve the acceptable risk-benefit ratio in asymptomatic participants, and disclose or not biomarker status with attention to study type (observational studies vs clinical trials). Overcoming these challenges will justify clinical trials in preclinical AD at the societal level and aid to the development of societal and legal support for trial participants.

Keywords: Alzheimer's disease; Asymptomatic; Ethics; Preclinical AD.

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Conflict of interest statement

Conflict of interest

José Luis Molinuevo has provided scientific advice or has been an investigator or data monitoring board member receiving consultancy fees from: Novartis, Pfizer, Eisai, Janssen-Cilag, Lundbeck, Roche, Bayer, Bristol-Myers Squibb, GE Health Care, Merz, MSD, GlaxoSmithKline, Astra-Zeneca, Avid, Lilly, Boehringer-Inghelmein, Biokit, Piramal, IBL and Fujireibio-Europe.

J Morris: Neither Dr. Morris nor his family own stock or have equity interest (outside of mutual funds or other externally directed accounts) in any pharmaceutical or biotechnology company. Dr. Morris has participated or is currently participating in clinical trials of antidementia drugs sponsored by the following companies: Janssen Immunotherapy, Pfizer, Eli Lilly/Avid Radiopharmaceuticals, SNIFF (The Study of Nasal Insulin to Fight Forgetfullness) study, and A4 (The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease) trial. Dr. Morris has served as a consultant for Lilly USA, ISIS Pharmaceuticals and Charles Dana Foundation.

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