search
Back to results

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

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease, Amnestic Mild Cognitive Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Disclosure Protocol
Biomarker Disclosure Protocol
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mild Cognitive Impairment focused on measuring AD Biomarkers, Alzheimer's Disease, Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diagnostic Disclosure

Biomarker and Diagnostic Disclosure

Arm Description

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/-).

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/-).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study
Measured by attendance at study visits

Secondary Outcome Measures

Full Information

First Posted
October 13, 2022
Last Updated
April 10, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05584241
Brief Title
Behavioral Change Following Alzheimer's Disease (AD) Biomarker Disclosure
Acronym
SHARED III
Official Title
Behavioral Change Following Culturally Informed Biomarker Disclosure in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease, Amnestic Mild Cognitive Disorder
Keywords
AD Biomarkers, Alzheimer's Disease, Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic Disclosure
Arm Type
Active Comparator
Arm Description
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/-).
Arm Title
Biomarker and Diagnostic Disclosure
Arm Type
Experimental
Arm Description
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/-).
Intervention Type
Behavioral
Intervention Name(s)
Diagnostic Disclosure Protocol
Intervention Description
Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
Intervention Type
Behavioral
Intervention Name(s)
Biomarker Disclosure Protocol
Intervention Description
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 Outcome Measure Information:
Title
Post-disclosure health behavior change as measured by the health behavior subscale score
Description
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
Title
Post-disclosure health behavior change as measured by the health communication subscale score
Description
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
Title
Post-disclosure health behavior change as measured by the advanced planning subscale score
Description
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
Title
Post-disclosure health behavior change as measured by the research engagement subscale score
Description
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
Title
Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study
Description
Measured by attendance at study visits
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annalise Rahman-Filipiak
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs