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

The Washington University

Status: Active, not recruiting

Conditions: Alzheimer Disease; Dementia of Alzheimer Type

Treatments: Other: Arm A , Arm B, Arm C, & Arm D

Study type: Interventional

Funder types: Other

Identifiers

NCT04699786

202011119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 4 patient groups

Arm A

Active Comparator group

Description:

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.

Treatment:

Other: Arm A , Arm B, Arm C, & Arm D

Arm B

Active Comparator group

Description:

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.

Treatment:

Other: Arm A , Arm B, Arm C, & Arm D

Arm C

Active Comparator group

Description:

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.

Treatment:

Other: Arm A , Arm B, Arm C, & Arm D

Arm D

Active Comparator group

Description:

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.

Treatment:

Other: Arm A , Arm B, Arm C, & Arm D