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，这些研究结果表明， 阿尔茨海默病（AD）的健康老年人参加了一个纵向队列的老化。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。伦理问题涉及到 告知个人他们患上一种高度恐惧的无法治愈的疾病的风险的潜在危害。的科学考虑方面 与认知测试结果的潜在变化有关，因为知道自己患AD的风险， 损害认知结果研究的科学完整性。但嘉宾 在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。返回 研究成果提供给那些希望获得它们的人，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社会和 认知结果，以负责任地设计未来的AD研究。 一项随机延迟开始的临床试验将评估将研究结果返回给参与者的影响， 老龄化的纵向研究。老龄化纵向队列的所有参与者都可以选择 接受最近PET淀粉样蛋白扫描，MRI和APOE基因型的研究结果，作为 综合5年AD风险。所有知情同意的受试者将随机接受 在两周内或一年后的研究结果。那些选择接收结果的人将被跟踪 长达24个月，以确定接收结果对认知和心理社会结果的影响。要求1 将定量和定性地探讨决定接受结果和拒绝或选择的原因 以获得结果。目标2将使用定量和定性分析来确定返回的效果 1年认知和心理社会结果的研究结果。目标3将评估可行性、可接受性， 和资源需求的结果的过程中，制定教育材料和培训 模块，供今后使用。 为研究成果的广泛回归奠定基础，这是第一次系统全面地 返回认知正常人参与AD生物标志物研究结果的方法。

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 scan, MRI, 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 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.