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Completed

NCT Number: NCT05584241

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

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Amnestic Mild Cognitive Disorder Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic Disclosure Protocol

Behavioral

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

Biomarker Disclosure Protocol

Behavioral

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.

Primary outcomes

  1. Post-disclosure health behavior change as measured by the health behavior subscale score

    Time frame: 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.

  2. Post-disclosure health behavior change as measured by the health communication subscale score

    Time frame: 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.

  3. Post-disclosure health behavior change as measured by the advanced planning subscale score

    Time frame: 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.

  4. Post-disclosure health behavior change as measured by the research engagement subscale score

    Time frame: 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.

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

    Time frame: Up to 24 months

    Measured by attendance at study visits

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: SHARED III

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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