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).