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

N/AActive Not RecruitingNCT05584241

University of Michigan100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

100

Conditions

Mild Cognitive Impairment Alzheimer Disease Amnestic Mild Cognitive Disorder

Interventions

Diagnostic Disclosure ProtocolBEHAVIORAL

Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.

Biomarker Disclosure ProtocolBEHAVIORAL

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

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

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.

Time frame: 6 months

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.

Time frame: 6 months

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.

Time frame: 6 months

Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study

Measured by attendance at study visits

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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