Behavioral Change Following Alzheimer's Disease (AD) Biomarker Disclosure

Not Applicable

• Conditions: Alzheimer Disease; Amnestic Mild Cognitive Disorder; Mild Cognitive Impairment
• Interventions: Behavioral: Diagnostic Disclosure Protocol; Behavioral: Biomarker Disclosure Protocol

• Registration Number: NCT05584241
• Lead Sponsor: University of Michigan

Brief Summary

The proposed project will assess long-term changes to health/lifestyle, advanced planning, and research engagement that Black and White patients with Amnestic Mild Cognitive Impairment (aMCI) make following disclosure of positron emission tomography-based amyloid and tau burden and associated risk of conversion to Dementia-Alzheimer's Type. Healthcare access will be explored as potential barrier to or facilitator of behavior change.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-18
• Study Start: 2023-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosed with Amnestic Mild Cognitive Impairment within the past 12 months,
• Available PET Aβ and tau imaging

Exclusion Criteria

• Significant neurologic diagnosis (e.g., Alzheimer's dementia or other neurodegenerative dementia, Parkinson's disease, seizure disorder, tumor, multiple sclerosis)
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diagnostic Disclosure	Diagnostic Disclosure Protocol	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/-).
Biomarker and Diagnostic Disclosure	Biomarker Disclosure Protocol	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/-).

Primary Outcome Measures

Name	Time	Method
Post-disclosure health behavior change as measured by the health behavior subscale score	6 months	Subscale is a part of the Stages of Change Interview. Respondents will rate seven items relating to behavioral changes they have made post-disclosure on a Likert scale ranging from 1 = "I have not considered/am not interested in making this change" to 5 = "I have already made and maintained this change." Subscale score total ranges from 7 to 35 with higher scores indicating more engagement.
Post-disclosure health behavior change as measured by the health communication subscale score	6 months	Subscale is a part of the Stages of Change Interview. Respondents will rate two items relating to health communication using a Likert scale. Subscale score total ranges from 2 to 10 with higher scores indicating more engagement.
Post-disclosure health behavior change as measured by the research engagement subscale score	6 months	Subscale is a part of the Stages of Change Interview. Respondents will rate one item relating to research engagement on a Likert scale. Subscale score total ranges from 1 to 5 with higher scores indicating more engagement.
Post-disclosure health behavior change as measured by the advanced planning subscale score	6 months	Subscale is a part of the Stages of Change Interview. Respondents will rate seven items relating to advanced planning using a Likert Scale. Subscale score total ranges from 7 to 35 with higher scores indicating more engagement.
Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study	Up to 24 months	Measured by attendance at study visits

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States