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. 2022 Aug 25;14(1):e12339.
doi: 10.1002/dad2.12339. eCollection 2022.

Implications of preclinical Alzheimer's disease biomarker disclosure for US policy and society

Claire M Erickson  1   2 , Lindsay R Clark  2   3 , Fred B Ketchum  4 , Nathaniel A Chin  2 , Carey E Gleason  2   3 , Emily A Largent  5
Affiliations

Implications of preclinical Alzheimer's disease biomarker disclosure for US policy and society

Claire M Erickson et al. Alzheimers Dement (Amst). .

Abstract

Disclosure of Alzheimer's disease (AD) biomarkers to cognitively unimpaired adults are currently conducted only in research settings. Yet, US Food and Drug Administration approval of a disease-modifying treatment for symptomatic individuals, improved understanding of the "preclinical" phase of disease, and advancements toward more accessible biomarker tests suggest such disclosure will increase in frequency, eventually becoming routine in clinical practice. The changing landscape in AD research to focus on biomarkers has generated debate on the validity and clinical utility of disclosure to cognitively unimpaired adults. This article explores the broader social implications of more widespread AD biomarker disclosure-that is, of individuals learning their risk for developing dementia caused by AD. We identify 10 challenges and offer preliminary solutions. As the field continues to evolve, it is essential to anticipate and address these broader ethical, legal, and social implications of disclosure.

Keywords: Alzheimer's disease; biomarker; caregiver; ethics; law; preclinical.

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Conflict of interest statement

The authors have no conflicts to disclose. Author disclosures are available in the supporting information.

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