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

Sponsor
University of Michigan (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05584241
Collaborator
National Institute on Aging (NIA) (NIH)
100
1
2
36.5
2.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diagnostic Disclosure Protocol
  • Behavioral: Biomarker Disclosure Protocol
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized delayed start design. Participants are randomized to receive, at baseline, either 'Diagnostic Disclosure Protocol' (cognitive testing/diagnosis) with an option to receive biomarker results after 6 months or 'Biomarker Disclosure Protocol' (cognitive testing, diagnosis, positron emission tomography-based amyloid and tau imaging. They are further categorized by biomarker status (+/positive or -/negative) for reporting purposes.Randomized delayed start design. Participants are randomized to receive, at baseline, either 'Diagnostic Disclosure Protocol' (cognitive testing/diagnosis) with an option to receive biomarker results after 6 months or 'Biomarker Disclosure Protocol' (cognitive testing, diagnosis, positron emission tomography-based amyloid and tau imaging. They are further categorized by biomarker status (+/positive or -/negative) for reporting purposes.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Behavioral Change Following Culturally Informed Biomarker Disclosure in Alzheimer's Disease
Actual Study Start Date :
Dec 16, 2022
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Post-disclosure health behavior change as measured by the health behavior subscale score [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 [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 [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 [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 [Up to 24 months]

    Measured by attendance at study visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • National Institute on Aging (NIA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Annalise Rahman-Filipiak, Assistant Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier:
NCT05584241
Other Study ID Numbers:
  • HUM00221221
  • 1K23AG070044-01
First Posted:
Oct 18, 2022
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Annalise Rahman-Filipiak, Assistant Professor of Psychiatry, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023