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

Alzheimer Disease Clinical Trial

— SHARED III  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05584241
• Other study ID #: HUM00221221
• Secondary ID: 1K23AG070044-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: August 2026

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Amnestic Mild Cognitive Impairment within the past 12 months,

• Available PET Aß 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-disclosure health behavior change as measured by the health behavior subscale score	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.	6 months
Primary	Post-disclosure health behavior change as measured by the health communication subscale score	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.	6 months
Primary	Post-disclosure health behavior change as measured by the advanced planning subscale score	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.	6 months
Primary	Post-disclosure health behavior change as measured by the research engagement subscale score	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.	6 months
Primary	Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study	Measured by attendance at study visits	Up to 24 months