Ethical challenges in preclinical Alzheimer's disease observational studies and trials: results of the Barcelona summit
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- dc.contributor.author Molinuevo, José Luisca
- dc.contributor.author Camí, Jordi, 1952-ca
- dc.contributor.author Carné, Xavierca
- dc.contributor.author Carrillo, Maria C.ca
- dc.contributor.author Georges, Jeanca
- dc.contributor.author Isaac, Maria B.ca
- dc.contributor.author Khachaturian, Zavenca
- dc.contributor.author Kim, Scott Y.H.ca
- dc.contributor.author Morris, John C.ca
- dc.contributor.author Pasquier, Florenceca
- dc.contributor.author Ritchie, Craigca
- dc.contributor.author Sperling, Reisaca
- dc.contributor.author Karlawish, Jasonca
- dc.date.accessioned 2016-06-17T12:26:23Z
- dc.date.available 2016-06-17T12:26:23Z
- dc.date.issued 2016
- dc.description.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.ca
- dc.description.sponsorship 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.
- dc.format.mimetype application/pdfca
- dc.identifier.citation Molinuevo JL, Cami J, Carné X, Carrillo MC, Georges J, Isaac MB et al. Ethical challenges in preclinical Alzheimer's disease observational studies and trials: results of the Barcelona summit. Alzheimer's & dementia. 2016;12(5):614-22. DOI: 10.1016/j.jalz.2016.01.009ca
- dc.identifier.doi http://dx.doi.org/10.1016/j.jalz.2016.01.009
- dc.identifier.issn 1552-5260
- dc.identifier.uri http://hdl.handle.net/10230/26942
- dc.language.iso engca
- dc.publisher Elsevierca
- dc.relation.ispartof Alzheimer's & dementia. 2016;12(5):614-22
- dc.relation.projectID info:eu-repo/grantAgreement/EC/FP7/115736
- dc.rights © 2016 The Authors. Published by Elsevier Inc. on behalf of Alzheimer’s Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)ca
- dc.rights.accessRights info:eu-repo/semantics/openAccessca
- dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/ca
- dc.subject.keyword Alzheimer’s disease
- dc.subject.keyword Preclinical AD
- dc.subject.keyword Ethics
- dc.subject.keyword Asymptomatic
- dc.subject.other Alzheimer, Malaltia d'ca
- dc.title Ethical challenges in preclinical Alzheimer's disease observational studies and trials: results of the Barcelona summitca
- dc.type info:eu-repo/semantics/articleca
- dc.type.version info:eu-repo/semantics/publishedVersionca