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

将表明阿尔茨海默病风险的研究结果返回给纵向研究中的健康参与者

• 批准号: 10528160
• 负责人: Sarah Hartz
• 金额: $ 39.36万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10528160
• 关键词: Aging; Alzheimer' s Disease; Alzheimer' s disease risk; Amyloid; Biological Markers; Clinical Trials; Cognitive; Consent; Disease; Educational Materials; Elderly; Enrollment; Ethics; Foundations; Fright; Future; Genotype; Individual; Longitudinal Studies; Longitudinal cohort; MRI Scans; Outcome; Participant; Persons; Plasma; Positron-Emission Tomography; Process; Randomized; Research; Resources; Risk; Test Result; Training Activity; cognitive testing; design; future implementation; psychosocial; research study

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.

项目摘要 该项目将确定返回研究结果的影响，这表明有5年的发展风险 阿尔茨海默氏病（AD）是纵向衰老队列的健康老年人的健康老年人。返回研究 出于道德和科学原因，表明AD风险的结果是有争议的。与之相关的道德问题 告知个人患有高度偏爱不可治疗疾病的风险的潜在危害。科学问题 由于知道自己的AD风险，与认知测试结果的潜在变化有关 损害了遵循认知结果的研究的科学完整性。但是，参与者 在对AD的纵向研究中，越来越多地要求他们的研究结果了解其AD风险。返回 为希望接收他们的人的研究结果尊重自主权并认可参与者的贡献 进行研究。需要证据来确定返回研究结果对心理心理和 认知结果可以被广泛设计为AD中的未来研究。 随机延迟启动临床试验将评估回归研究结果对参与者的影响 衰老的纵向研究。纵向衰老队列的所有参与者都将选择 从最近的宠物淀粉样蛋白和MRI扫描或血浆淀粉样蛋白（Precitive AD©）中获得研究结果，以及 APOE基因型作为合成的5年开发AD风险。所有同意的参与者将是 随机分配在2-4周内或1年后接受其研究结果。那些选择 接收结果最多24个月，以确定接收结果对认知的影响 和社会心理成果。 AIM 1将在定性上探索获得结果的决定 以及下降或选择接收结果的原因。 AIM 2将使用定量和定性分析来 确定返回研究结果对1年认知和社会心理结局的影响。目标3意志 评估结果返回过程的可行性，可接受性和资源要求 教育材料和未来实施的培训模块。 为研究结果的宽度回报奠定了基础，这是第一个系统的，全面的 回归研究的方法结果是从事AD生物标志物研究的认知正常人。