NCT05584241

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

Behavioral Change Following Culturally Informed Biomarker Disclosure in Alzheimer's Disease

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment
• Alzheimer Disease
• Amnestic Mild Cognitive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Diagnostic Disclosure Protocol	Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
BEHAVIORAL	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.

Timeline

• Start date: 2023-02-20
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-10-18
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States