@article{96cf7083924545b99dfb5839f2f9e76c,
title = "Ethical challenges in preclinical Alzheimer's disease observational studies and trials: Results of the Barcelona summit",
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",
author = "Molinuevo, {Jos{\'e} L.} and Jordi Cami and Xavier Carn{\'e} and Carrillo, {Maria C.} and Jean Georges and Isaac, {Maria B.} and Zaven Khachaturian and Kim, {Scott Y.H.} and Morris, {John C.} and Florence Pasquier and Craig Ritchie and Reisa Sperling and Jason Karlawish",
note = "Funding Information: The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no 115736 , resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007–2013) and EFPIA companies' in kind contribution. The authors thank Karine Fauria and Carolina Minguill{\'o}n for their assistance with this article preparation and for the logistical planning of the summit. They thank as well the institutions that have supported the realization of the summit: “Obra social la Caixa” for the summit venue at “Caixa Forum”; Roche, Novartis, Lilly, Lumbeck, and Janssen for logistic support; and the Pasqual Maragall Foundation for the summit organization. The authors of this article presented and discussed their views throughout the meeting. Publisher Copyright: {\textcopyright} 2016 Alzheimer's Association. Published by Elsevier Inc. All rights reserved.",
year = "2016",
month = may,
day = "1",
doi = "10.1016/j.jalz.2016.01.009",
language = "English",
volume = "12",
pages = "614--622",
journal = "Alzheimer's and Dementia",
issn = "1552-5260",
number = "5",
}