Abstract
IntroductionReturning research results that indicate risk of Alzheimer disease (AD)-a disease for which no meaningful treatments or cure exist-to cognitively normal participants is controversial. AD is thought to begin many years before clinical signs and symptoms begin. During this time, individuals are cognitively normal, but have biomarkers that indicate pathophysiological changes in the brain. With this study, we aim to evaluate impact of returning research results on cognitively normal participants recruited from a longitudinal observational cohort on aging at the Knight Alzheimer Research Center (Knight ADRC) at Washington University in St. Louis.Methods and analysisOur study uses a 2-year, delayed-start randomized clinical trial design. Participants are randomized to receive their research results either in 2-4 weeks or 1 year after informed consent. We plan to approach approximately 260 participants who have research results from previous genetic and biomarker testing at the Knight ADRC. The primary cognitive outcomes are 1-year change in subjective cognitive score (Clinical Dementia Rating (CDR) ® sum of boxes), objective cognitive score (psychometric composite score), and the primary psychosocial outcome is Impact of Event-Revised (IES_R) score 1 year after return of research results.Ethics and disseminationThis study has been approved by WUSM Institutional Review Board and the Human Research Protection Office. Results from these trials are shared through conferences and publications.Trial registration numberNCT04699786.
Publisher
Cold Spring Harbor Laboratory