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

José L. Molinuevo, Jordi Cami, Xavier Carné, Maria C. Carrillo, Jean Georges, Maria B. Isaac, Zaven Khachaturian, Scott Y H Kim, John C. Morris, Florence Pasquier, Craig Ritchie, Reisa Sperling, Jason Karlawish

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)614-622
Number of pages9
JournalAlzheimer's and Dementia
Volume12
Issue number5
DOIs
StatePublished - May 1 2016
Externally publishedYes

Fingerprint

Observational Studies
Alzheimer Disease
Clinical Trials
Biomarkers
Odds Ratio
Vocabulary
Delivery of Health Care
Research
Therapeutics

Keywords

  • Alzheimer's disease
  • Asymptomatic
  • Ethics
  • Preclinical AD

ASJC Scopus subject areas

  • Clinical Neurology
  • Developmental Neuroscience
  • Cellular and Molecular Neuroscience
  • Psychiatry and Mental health
  • Geriatrics and Gerontology
  • Epidemiology
  • Health Policy

Cite this

Molinuevo, J. L., Cami, J., Carné, X., Carrillo, M. C., Georges, J., Isaac, M. B., ... Karlawish, J. (2016). Ethical challenges in preclinical Alzheimer's disease observational studies and trials: Results of the Barcelona summit. Alzheimer's and Dementia, 12(5), 614-622. https://doi.org/10.1016/j.jalz.2016.01.009

Ethical challenges in preclinical Alzheimer's disease observational studies and trials : Results of the Barcelona summit. / Molinuevo, José L.; Cami, Jordi; Carné, Xavier; Carrillo, Maria C.; Georges, Jean; Isaac, Maria B.; Khachaturian, Zaven; Kim, Scott Y H; Morris, John C.; Pasquier, Florence; Ritchie, Craig; Sperling, Reisa; Karlawish, Jason.

In: Alzheimer's and Dementia, Vol. 12, No. 5, 01.05.2016, p. 614-622.

Research output: Contribution to journalArticle

Molinuevo, JL, Cami, J, Carné, X, Carrillo, MC, Georges, J, Isaac, MB, Khachaturian, Z, Kim, SYH, Morris, JC, Pasquier, F, Ritchie, C, Sperling, R & Karlawish, J 2016, 'Ethical challenges in preclinical Alzheimer's disease observational studies and trials: Results of the Barcelona summit', Alzheimer's and Dementia, vol. 12, no. 5, pp. 614-622. https://doi.org/10.1016/j.jalz.2016.01.009
Molinuevo, José L. ; Cami, Jordi ; Carné, Xavier ; Carrillo, Maria C. ; Georges, Jean ; Isaac, Maria B. ; Khachaturian, Zaven ; Kim, Scott Y H ; Morris, John C. ; Pasquier, Florence ; Ritchie, Craig ; Sperling, Reisa ; Karlawish, Jason. / Ethical challenges in preclinical Alzheimer's disease observational studies and trials : Results of the Barcelona summit. In: Alzheimer's and Dementia. 2016 ; Vol. 12, No. 5. pp. 614-622.
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