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

N/AActive Not RecruitingNCT04699786

Washington University School of Medicine450 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

450

Conditions

Alzheimer Disease Dementia of Alzheimer Type

Interventions

Arm A , Arm B, Arm C, & Arm DOTHER

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.

Secondary Outcomes

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.

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

Decision Regret Scale

The Decision Regret Scale measures "distress or remorse" after receiving research results.

Time frame: 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.

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

Data from ClinicalTrials.gov

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