Behavioral Change Following Alzheimer's Disease (AD) Biomarker Disclosure
NCT ID: NCT05584241
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2023-02-20
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Diagnostic Disclosure
Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
For reporting purposes those participants randomized to this condition are analyzed by biomarker status (positive/+ or negative/-).
Diagnostic Disclosure Protocol
Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
Biomarker and Diagnostic Disclosure
Participants receive information about their cognitive test results and research diagnosis. In addition, participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging. PET is a type of imaging biomarker (Aß-PET and tau PET) for clinical diagnosis of Alzheimer's disease. These actions are followed by post-disclosure dementia risk reduction counseling.
For reporting purposes those participants randomized to this condition are analyzed by biomarker status (positive/+ or negative/-).
Biomarker Disclosure Protocol
Participants receive information about their cognitive test results and research diagnosis just like in the diagnostic disclosure protocol. In addition, participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging. PET is a type of imaging biomarker (Aß-PET and tau PET) for clinical diagnosis of Alzheimer's disease. These actions are followed by post-disclosure dementia risk reduction counseling.
Interventions
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Diagnostic Disclosure Protocol
Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
Biomarker Disclosure Protocol
Participants receive information about their cognitive test results and research diagnosis just like in the diagnostic disclosure protocol. In addition, participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging. PET is a type of imaging biomarker (Aß-PET and tau PET) for clinical diagnosis of Alzheimer's disease. These actions are followed by post-disclosure dementia risk reduction counseling.
Eligibility Criteria
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Inclusion Criteria
* Available PET Aβ and tau imaging
Exclusion Criteria
* Neurologic injury (e.g., significant stroke or moderate-severe head injury, defined by loss of consciousness \> 5 minutes, presence of significant post-traumatic amnesia, or the need for extended hospitalization or intervention)
* Motor abnormalities indicative of a non-AD etiology
* Severe mental illness (e.g., bipolar disorder, psychosis), moderate-severe mood or anxiety disorder, active substance use disorder (o reduce the likelihood of severe psychological distress, participants must screen negative for moderate-severe depressive or anxiety symptoms at study enrollment.)
* Inability to provide independent informed consent.
50 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Michigan
OTHER
Responsible Party
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Annalise Rahman-Filipiak
Assistant Professor of Psychiatry
Principal Investigators
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Annalise Rahman-Filipiak
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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The University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00221221
Identifier Type: -
Identifier Source: org_study_id
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