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

August 12, 2026 updated by: Annalise Rahman-Filipiak, University of Michigan

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • The University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diagnostic Disclosure

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/-).
Behavioral: Diagnostic Disclosure Protocol
Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
Experimental: Biomarker and Diagnostic Disclosure

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/-).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Annalise Rahman-Filipiak, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

May 7, 2026

Study Completion (Actual)

May 21, 2026

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00221221
  • 1K23AG070044-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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