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

doi:10.1016/j.jalz.2016.01.009

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 journal › Article › peer-review

29 Scopus citations

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 language	English (US)
Pages (from-to)	614-622
Number of pages	9
Journal	Alzheimer's and Dementia
Volume	12
Issue number	5
DOIs	https://doi.org/10.1016/j.jalz.2016.01.009
State	Published - May 1 2016
Externally published	Yes

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

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10.1016/j.jalz.2016.01.009

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Molinuevo, J. L., Cami, J., Carné, X., Carrillo, M. C., Georges, J., Isaac, M. B., Khachaturian, Z., Kim, S. Y. H., Morris, J. C., 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, 12(5), 614-622. https://doi.org/10.1016/j.jalz.2016.01.009

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

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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.",

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AU - Carrillo, Maria C.

AU - Georges, Jean

AU - Isaac, Maria B.

AU - Khachaturian, Zaven

AU - Kim, Scott Y H

AU - Morris, John C.

AU - Pasquier, Florence

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AU - Karlawish, Jason

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KW - Alzheimer's disease

KW - Asymptomatic

KW - Ethics

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

Abstract

Keywords

ASJC Scopus subject areas

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