Impact of Disclosing Amyloid Imaging Results to Cognitively Normal Individuals

公开淀粉样蛋白成像结果对认知正常个体的影响

• 批准号: 9518218
• 负责人: Robert C. Green
• 金额: $ 11.45万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-20 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9518218
• 关键词: Address; African American; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease risk; Amyloid; Apolipoproteins; Behavioral; Biological Markers; Brain; Brain Pathology; Brain imaging; Clinical Investigator; Clinical Trials; Cognitive; Communication; Complex; Data; Dementia; Disclosure; Disease; Enrollment; Ethnic group; Event; Funding; Future; Genotype; Goals; Health Planning; Health behavior; Impaired cognition; Individual; Knowledge; Learning; Long-Term Care Insurance; Measures; Memory; Minority; Neuropsychology; Outcome; Outcome Measure; Participant; Performance; Persons; Population Heterogeneity; Positron-Emission Tomography; Prevention trial; Process; Protocols documentation; Psychological Impact; Quality of life; Race; Randomized; Randomized Clinical Trials; Reading; Recruitment Activity; Research Personnel; Risk; Safety; Sampling; Scanning; Site; Stereotyping; Suggestion; Symptoms; Test Result; Testing; Time; Translations; United States National Institutes of Health; Work; aged; amyloid imaging; behavior change; clinical practice; cognitive performance; cognitive testing; disorder prevention; expectation; high risk; imaging modality; neuroethics; outreach; pre-clinical; preclinical study; primary outcome; psychologic; psychological distress; psychological outcomes; public health relevance; racial diversity; response; risk variant; social; social stigma

 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).

 描述（由申请人提供）：预防阿尔茨海默病 (AD) 的临床试验已开始在越来越早的时间点招募受试者，现在重点关注认知正常但具有与阿尔茨海默氏病风险增加相关的生物标志物的人。使用此类生物标志物进行丰富的试验提出了两个对 AD 试验未来的有效性和安全性至关重要的基本问题：受试者对其生物标志物状态的了解是否会影响试验的认知结果？这些知识是否会导致不良心理后果？ ？在这项研究中，将制定并实施风险沟通协议来传达淀粉样蛋白 PET 脑成像结果，然后，将招募 270 名年龄在 65-80 岁之间认知正常的个体（约 25% 为非洲裔美国人）并随机接受淀粉样蛋白扫描结果。或不公开，导致扫描结果是否公开以及扫描结果是否为淀粉样蛋白阳性的受试者以及对 e4+ 个体进行过采样的 APOE 基因分型将用于丰富登记。样本中，大约一半的扫描结果为淀粉样蛋白阳性，一半为淀粉样蛋白阴性。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指标（ADCS-PACC），而心理困扰的主要心理结果将是影响。事件量表 (IES) 本研究的具体目的是 1) 确定大脑淀粉样蛋白升高是否会导致 ADCS 临床前阿尔茨海默病认知复合物产生偏差。 (ADCS-PACC) 测试结果；2) 确定大脑淀粉样蛋白升高是否会导致心理困扰；3) 探索学习淀粉样蛋白成像信息如何影响预防性健康行为，提前制定健康计划（例如长期护理保险）决定）和福祉（例如耻辱、生活质量和人际关系）。