Implications of preclinical Alzheimer's disease biomarker disclosure for US policy and society.
Implications of preclinical Alzheimer's disease biomarker disclosure for US policy and society.
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DOI：
10.1002/dad2.12339
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发表时间：
2022
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阿尔茨海默病（AD）生物标志物目前仅在研究环境中向认知未受损的成年人披露。然而，美国食品和药物管理局（fda）批准了一种针对有症状个体的疾病修饰治疗，提高了对疾病“临床前”阶段的理解，以及更容易获得的生物标志物检测的进步，这些都表明，此类披露将增加频率，最终成为临床实践中的常规方法。阿尔茨海默病研究领域的变化主要集中在生物标志物上，这引发了关于向认知未受损的成年人披露信息的有效性和临床效用的争论。这篇文章探讨了更广泛的阿尔茨海默病生物标志物披露的更广泛的社会影响，即个人了解他们患阿尔茨海默病引起的痴呆的风险。我们确定了10个挑战，并提供了初步解决方案。随着这一领域的不断发展，预测和解决这些更广泛的披露的伦理、法律和社会影响是至关重要的。
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.