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

University of Michigan

Status: Active, not recruiting

Conditions: Alzheimer Disease; Amnestic Mild Cognitive Disorder; Mild Cognitive Impairment

Treatments: Behavioral: Diagnostic Disclosure Protocol; Behavioral: Biomarker Disclosure Protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05584241

HUM00221221

1K23AG070044-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Diagnostic Disclosure

Active Comparator group

Description:

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/-).

Treatment:

Behavioral: Diagnostic Disclosure Protocol

Biomarker and Diagnostic Disclosure

Experimental group

Description:

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/-).

Treatment:

Behavioral: Biomarker Disclosure Protocol