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

NCT04699786 | Active Not Recruiting

• 1 other identifier: 202011119
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia of Alzheimer Type

Keywords

Dementia; Alzheimer disease dementia; genetics; neuroimaging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Impact of Events Scale Revised (IES-R)

  2, 6, 12 and 24 months post-disclosure of risk estimate.

• Decision Regret Scale

  2, 6, 12 and 24 months post-disclosure of risk estimate.

• Self- Report Heath Care Utilization

  At consent, 6, 12 and 24 months post-disclosure of risk estimate

• Understanding of Research Results

  2, 12 and 24 months post-disclosure of risk estimate.

• Patient Assessment of Communication Effectiveness

  2 months post-disclosure of risk estimate.

Study Arms (4)

Arm A

ACTIVE COMPARATOR

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

Arm B

ACTIVE COMPARATOR

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

Arm C

ACTIVE COMPARATOR

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

Arm D

ACTIVE COMPARATOR

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

Interventions

Arm A , Arm B, Arm C, & Arm D OTHER

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.

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 41500647 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sarah Hartz, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 7, 2021
• Study Start: February 19, 2021
• Primary Completion: June 10, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Data will be available immediately following publication with no end date.
• 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.

Locations

US (1)