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

• ClinicalTrials.gov Identifier: NCT04699786
• Recruitment Status: Enrolling by invitation
• First Posted: January 7, 2021
• Last Update Posted: July 7, 2023
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Dementia of Alzheimer Type	Other: Arm A , Arm B, Arm C, & Arm D	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies: Quantitative Analyses of a Randomized Clinical Trial
• Actual Study Start Date: February 19, 2021
• Estimated Primary Completion Date: February 1, 2025
• Estimated Study Completion Date: February 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Impact of Events Scale (IES) [ Time Frame: 12 months post-disclosure of risk estimate ]
   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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Current Knight ADRC participants who had their clinical assessment in the previous month.
• Minimum age of 65 years old
• Participant must be classified as cognitively normal (CDR® = 0) at their last clinical assessment.
• Participant has had brain MRI and/or PET amyloid scan within the last 24 months or has plasma amyloid results.
• 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.

Contacts and Locations

Locations

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

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

More Information

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04699786
• Other Study ID Numbers: 202011119
• First Posted: January 7, 2021
• Last Update Posted: July 7, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Statistical Analysis Plan (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:

Dementia; Alzheimer disease dementia; genetics; neuroimaging

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders