Impact of Disclosing Amyloid Imaging Results to Cognitively Normal Individuals

 描述(申请人提供)：预防阿尔茨海默病(AD)的临床试验已经转移到越来越早的时间点招募受试者，现在集中在认知正常但具有与AD发病风险增加相关的生物标记物的个人。用这样的生物标记物丰富试验提出了两个基本问题，这两个问题对AD试验的未来有效性和安全性至关重要。受试者对其生物标记物状态的了解是否会影响试验的认知结果？这样的知识会不会造成不良的心理后果？在这项研究中，将开发和实施风险沟通协议，以传达淀粉样蛋白PET脑成像结果。然后，270名认知正常的人(大约25%的非裔美国人)，年龄在65-80岁之间，将被招募并随机接收他们的淀粉样扫描结果或不接收，结果是扫描结果被披露或未披露的受试者以及扫描结果为淀粉样阳性或非淀粉样蛋白的受试者。将使用对e4+个体进行过采样的APOE基因分型来丰富登记样本，这样扫描的样本中大约有一半是淀粉样阳性，一半是淀粉样阴性。主要的神经心理学结果将是ADCS临床前阿尔茨海默病认知综合量表(ADCS-PACC)，而心理困扰的主要心理结果将是事件影响量表(IES)。本研究的具体目的是1)确定大脑淀粉样蛋白升高的披露是否会影响ADCS-临床前阿尔茨海默病认知综合测试(ADCS-PACC)的测试结果；2)确定大脑淀粉样蛋白升高的披露是否会导致心理痛苦；以及3)探索学习淀粉样蛋白成像披露将如何影响预防性健康行为、提前规划健康(如长期护理保险决定)和幸福感(如耻辱、生活质量和人际关系)。

 DESCRIPTION (provided by applicant): Clinical trials for the prevention of Alzheimer's disease (AD) have been moving to enroll subjects at increasingly early time-points, and are now focusing upon individuals who are cognitively normal, but have biomarkers associated with an increased risk of developing AD. Enriching trials with such biomarkers presents two fundamental concerns that are of critical importance to the future validity and safety of AD trials Will a subject's knowledge of their biomarker status bias the cognitive outcomes of the trial? And will such knowledge cause adverse psychological consequences? In this study, risk communication protocols will be developed and implemented for communicating amyloid PET brain imaging results. Then, 270 cognitively normal individuals (approximately 25% African American), aged 65-80, will be recruited and randomized to receive their amyloid scan results or not, resulting in subjects whose scan results are disclosed or not and subjects whose scans are amyloid positive or not. APOE genotyping with oversampling of e4+ individuals will be used to enrich the enrollment sample, such that roughly half of those scanned will be amyloid positive and half will be amyloid negative. The primary neuropsychological outcome will be the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) and the primary psychological outcome for psychological distress will be the Impact of Events Scale (IES). The Specific Aims of this study are 1) to determine whether disclosure of elevated brain amyloid will bias ADCS-Preclinical Alzheimer Cognitive Composite (ADCS-PACC) test results; 2) to determine whether disclosure of elevated brain amyloid will cause psychological distress; and 3) to explore how learning amyloid imaging disclosure will impact preventative health behaviors, advance planning for health (e.g. long-term care insurance decisions) and well-being (e.g. stigma, quality of life and relationships).