NCT04699786

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

Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies: Quantitative Analyses of a Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the impact of returning research results that indicate a five-year risk estimate of Alzheimer disease dementia to participants without memory or thinking problems of the Knight Alzheimer Disease Research Center at Washington University in St. Louis.

Detailed description

All participants without memory or thinking problems in a longitudinal observational cohort of aging (Memory and Aging Project) will be offered a five-year Alzheimer dementia risk estimate report that incorporates genetic and either neuroimaging research results or plasma amyloid results as well as demographic information into five-year Alzheimer disease dementia risk estimate. Using a two-year delayed-start randomized clinical trial design, participants will be randomized to receive research results either two weeks (Arm A/C) or one year (Arm B/D) after informed consent.

Conditions

• Alzheimer Disease
• Dementia of Alzheimer Type

Interventions

Type	Name	Description
OTHER	Arm A , Arm B, Arm C, & Arm D	All arms will receive the same intervention, but at different time points. All arms will be offered the option to learn their research results in personalized five-year risk estimate of getting Alzheimer disease dementia. Arms A \& C participants will receive their risk estimate about two weeks after consent is signed and Arms B\& D will receive their risk estimate about one year after consent is signed. The risk estimate returned to participants is based on research results from individual genotyping results, imaging or plasma amyloid testing \& demographic characteristics. All arms will complete psychosocial and cognitive testing. Also, surveys used in this study will ask about participants' experiences and feelings after learning their risk estimate. All arms will receive follow up calls at one week post disclosure of the risk estimate and surveys two, six, and twelve months post disclosure. Arms A \& C will have extra surveys at twenty-four months post disclosure.

Timeline

• Start date: 2021-02-19
• Primary completion: 2025-06-10
• Completion: 2026-06-01
• First posted: 2021-01-07
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States