Ethical challenges in preclinical alzheimer's ...
Document type :
Article dans une revue scientifique: Article original
PMID :
Permalink :
Title :
Ethical challenges in preclinical alzheimer's disease observational studies and trials: results of the barcelona summit
Author(s) :
Molinuevo, Jose Luis [Auteur]
Cami, Jordi [Auteur]
Carne, Xavier [Auteur]
Carrillo, Maria C. [Auteur]
Georges, Jean [Auteur]
Isaac, Maria B. [Auteur]
Khachaturian, Zaven [Auteur]
Kim, Scott Y H. [Auteur]
Morris, John C. [Auteur]
Pasquier, Florence [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U1171
Ritchie, Craig [Auteur]
Sperling, Reisa [Auteur]
Karlawish, Jason [Auteur]
Cami, Jordi [Auteur]
Carne, Xavier [Auteur]
Carrillo, Maria C. [Auteur]
Georges, Jean [Auteur]
Isaac, Maria B. [Auteur]
Khachaturian, Zaven [Auteur]
Kim, Scott Y H. [Auteur]
Morris, John C. [Auteur]
Pasquier, Florence [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U1171
Ritchie, Craig [Auteur]
Sperling, Reisa [Auteur]
Karlawish, Jason [Auteur]
Journal title :
Alzheimer's & dementia . the journal of the Alzheimer's Association
Abbreviated title :
Alzheimers. Dement.
Volume number :
12
Pages :
614-622
Publication date :
2016-05-01
ISSN :
1552-5260
English keyword(s) :
Alzheimer''s disease
Asymptomatic
Ethics
Preclinical AD
Asymptomatic
Ethics
Preclinical AD
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
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 ...
Show more >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.Show less >
Show more >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.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
CNRS
Inserm
Université de Lille
CNRS
Inserm
Université de Lille
Collections :
Research team(s) :
Troubles cognitifs dégénératifs et vasculaires
Submission date :
2019-11-27T13:38:07Z