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

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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.