Returning Research Results that Indicate Risk of Alzheimer Disease to Healthy Participants in Longitudinal Studies

项目摘要 该项目将确定返回的研究结果的影响，这些结果表明开发的5年风险 阿尔茨海默病(AD)对健康的老年人登记在纵向老龄化队列中。回归研究 由于伦理和科学原因，表明AD风险的结果是有争议的。伦理方面的关切与 告知个人他们患上一种令人高度恐惧的无法治愈的疾病的风险的潜在危害。科学关注点 与认知测试结果的潜在变化有关，因为知道一个人患AD的风险，潜在地 损害认知结果之后的研究研究的科学完整性。然而，参与者 在对AD的纵向研究中，越来越多的人要求他们的研究结果来了解他们的AD风险。归来 希望获得研究成果的人尊重自主权并承认参与者的贡献 去做研究。需要证据来确定返回的研究结果对心理和社会的影响 认知结果，以负责任地设计未来的AD研究。 一项随机延迟启动的临床试验将评估将研究结果返回给参与者的影响 关于衰老的纵向研究。纵向老龄化队列的所有参与者都将被提供选项 从最近的PET淀粉样蛋白和MRI扫描或血浆淀粉样蛋白(PrecivityAD©)获得研究结果，以及 APOE基因，被认为是发展为AD的综合5年风险。所有同意的参与者都将是 随机在2-4周内或一年后收到他们的研究结果。那些选择的人 接收结果将被跟踪长达24个月，以确定接收结果对认知的影响 以及心理社会结果。目标1将定量和定性地探讨接收结果的决定 以及拒绝或选择接受结果的原因。目标2将使用定量和定性分析来 确定返回研究结果对一年的认知和心理社会结果的影响。目标3将 评估返回结果流程的可行性、可接受性和资源需求，并制定 教育材料和一个培训模块，以供今后实施。 为研究成果的广泛回归奠定了基础，这是第一次系统全面的 认知正常人群进行阿尔茨海默病生物标志物研究的研究成果返回途径。

Project Summary This project will determine the impact of returning research results that indicate 5-year risk of developing Alzheimer Disease (AD) to healthy older adults enrolled in a longitudinal cohort of aging. Returning research results that indicate risk of AD is controversial for ethical and scientific reasons. Ethical concerns relate to the potential harms of informing individuals their risk of a highly feared untreatable disease. Scientific concerns relate to the potential change in cognitive test results due to knowing one’s risk of AD, potentially compromising the scientific integrity of research studies that follow cognitive outcomes. However, participants in longitudinal studies of AD increasingly ask for their research results to understand their AD risk. Returning research results to those who wish to receive them respects autonomy and recognizes participant contributions to research. Evidence is needed to determine the impact of returning research results on psychosocial and cognitive outcomes to responsibly design future studies in AD. A randomized delayed-start clinical trial will evaluate the impact of returning research results to participants in longitudinal studies of aging. All participants of a longitudinal cohort of aging will be offered the option to receive research results from a recent PET amyloid and MRI scan, or plasma amyloid (Precivity AD©), and APOE genotype, presented as a synthesized 5-year risk of developing AD. All consenting participants will be randomized to either receiving their research results within 2-4 weeks or after 1 year. Those who choose to receive results will be followed for up to 24 months to determine the impact of receiving results on cognitive and psychosocial outcomes. Aim 1 will quantitatively and qualitatively explore the decision to receive results and reasons for declining or choosing to receive results. Aim 2 will use quantitative and qualitative analyses to determine the effect of returning research results on 1-year cognitive and psychosocial outcomes. Aim 3 will assess feasibility, acceptability, and resource requirements of the return of results process and develop educational materials and a training module for future implementation. Laying the foundation for widespread return of research results, this is the first systematic and comprehensive approach to returning research results in cognitively normal persons engaged in biomarker studies of AD.