Clinical trial NCT04699786: Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia of Alzheimer Type
Keywords: Dementia
Alzheimer disease dementia
genetics
neuroimaging
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 450
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Geriatric Depression Scale (GDS)
timeFrame: 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.
measure: Change in Clinical Dementia Rating sum of box score (CDR-SB)
timeFrame: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.
measure: Change in cognitive composite score
timeFrame: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.
Secondary outcomes:
measure: Impact of Events Scale Revised (IES-R)
timeFrame: 2, 6, 12 and 24 months post-disclosure of risk estimate.
measure: Decision Regret Scale
timeFrame: 2, 6, 12 and 24 months post-disclosure of risk estimate.
measure: Self- Report Heath Care Utilization
timeFrame: At consent, 6, 12 and 24 months post-disclosure of risk estimate
measure: Understanding of Research Results
timeFrame: 2, 12 and 24 months post-disclosure of risk estimate.
measure: Patient Assessment of Communication Effectiveness
timeFrame: 2 months post-disclosure of risk estimate.
measure: Lifestyle/Health Behavior Change
timeFrame: 6, 12 and 24 months post-disclosure of risk estimate.
measure: AD-Related Distress
timeFrame: At consent, 2, 6, 12 and 24 months post-disclosure of risk estimate.
measure: Future Time Perspective
timeFrame: At consent, 12 and 24 months post-disclosure of risk estimate.
measure: Modified Social Impact Scale
timeFrame: 2, 6, 12 and 24 months post-disclosure of risk estimate.
measure: Views Regarding Research
timeFrame: At consent, 6 and 12 months post-disclosure of risk estimate.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Sarah Hartz, MD
role: PRINCIPAL_INVESTIGATOR
References: