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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease; Dementia of Alzheimer Type
• Intervention / Treatment: Other: Arm A , Arm B, Arm C, & Arm D

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.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current Knight ADRC participants who had their clinical assessment in the previous year.
• Minimum age of 65 years old
• Participant must be classified as cognitively normal (CDR® = 0) at their last clinical assessment.
• Participant has either recent research brain MRI and amyloid PET scan results, or recent plasma amyloid measurements (ideally within the past two years, but up to five years will be acceptable due to COVID-19-related delays).
• Participant has genetic research results available including APOE status.
• Participant is currently consented to be contacted for other research opportunities through the Knight ADRC.

Exclusion Criteria:

• There are no exclusion criteria, other than not meeting all of the inclusion criteria listed above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; Participants randomized to Arm A will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm A is a neuroimaging arm.	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.
Active Comparator: Arm B; Participants randomized to Arm B will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm B is a neuroimaging arm.	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.
Active Comparator: Arm C; Participants randomized to Arm C will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm C is a plasma amyloid arm.	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.
Active Comparator: Arm D; Participants randomized to Arm D will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm D is a plasma amyloid arm.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Geriatric Depression Scale (GDS)	GDS is a questionnaire that screens for depression in older adults. It's a self-report tool that asks yes or no questions about how a person has been feeling over the past week.	Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial. GDS is also measured at the time of informed consent.
Change in Clinical Dementia Rating sum of box score (CDR-SB)	Subjective measure of dementia determined as part of clinical assessment.	Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.
Change in cognitive composite score	Objective measure of cognitive functioning.	Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision Regret Scale	The Decision Regret Scale measures "distress or remorse" after receiving research results.	2, 6, 12 and 24 months post-disclosure of risk estimate.
Understanding of Research Results	The scale measures participant's comprehension of their research results.	2, 12 and 24 months post-disclosure of risk estimate.
Patient Assessment of Communication Effectiveness	This scale investigates participants' perspectives on communication and to measure how well the research team communicated research results to participants	2 months post-disclosure of risk estimate.
Lifestyle/Health Behavior Change	This scale gauges self-reported preparedness of future health and end of life situations.	6, 12 and 24 months post-disclosure of risk estimate.
Modified Social Impact Scale	This scale assesses whether participant's self-image after learning research results indicating risk of developing AD dementia is affected by notions of stigma.	2, 6, 12 and 24 months post-disclosure of risk estimate.
Impact of Events Scale Revised (IES-R)	A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.	2, 6, 12 and 24 months post-disclosure of risk estimate.
Self- Report Heath Care Utilization	This scale measures self-reported health care utilization that indicates both patients' health and their ability to self-manage their condition.	At consent, 6, 12 and 24 months post-disclosure of risk estimate
AD-Related Distress	This scale measures participants' self-reported anxiety (psychological impact) about developing AD dementia.	At consent, 2, 6, 12 and 24 months post-disclosure of risk estimate.
Future Time Perspective	This scale measures how participants' feel about future events and their self-reported agreement or disagreement with the future events.	At consent, 12 and 24 months post-disclosure of risk estimate.
Views Regarding Research	This scale assesses the impact of learning research results on attitudes towards research participation.	At consent, 6 and 12 months post-disclosure of risk estimate.

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Sarah Hartz, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Hartz SM, Goswami S, Oliver A, Evans A, Jackson S, Linnenbringer E, Moulder KM, Morris JC, Mozersky J. What is the psychological and cognitive impact of returning Alzheimer disease dementia research results to healthy research participants? a delayed-start randomised clinical trial protocol for the WeSHARE study (Washington University study of having Alzheimer disease research results explained). BMJ Open. 2026 Jan 6;16(1):e099970. doi: 10.1136/bmjopen-2025-099970.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): June 10, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: genetics; neuroimaging; Dementia; Alzheimer disease dementia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 202011119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be de-identified to prevent the disclosure of personal identifiers.
• IPD Sharing Time Frame: Data will be available immediately following publication with no end date.

IPD Sharing Access Criteria

Access Criteria: Qualified researchers who provide a methodologically sound proposal will be able to access the data to achieve aims in the approved proposal.

Proposals should be directed to hartzs@wustl.edu. To gain access, requestors will need to sign a data access agreement.

• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No