Mild Cognitive ImpairmentSHARED IIINCT05584241
Behavioral Change Following Alzheimer's Disease (AD) Biomarker Disclosure
A study testing Diagnostic Disclosure Protocol and Biomarker Disclosure Protocol in people with Mild Cognitive Impairment and Alzheimer Disease, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Amnestic Mild Cognitive Disorder
- What is being tested?
- Diagnostic Disclosure Protocol and Biomarker Disclosure Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Amnestic Mild Cognitive Impairment within the past 12 months,
- Available PET Aβ and tau imaging
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
- Being tested
- Diagnostic Disclosure Protocol, Biomarker Disclosure Protocol
- Keywords
- AD Biomarkers, Alzheimer's Disease, Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Disclosure ProtocolBehavioural
Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
Biomarker Disclosure ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Disclosure | Active comparator | 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/-). Receives: Behavioral: Diagnostic Disclosure Protocol |
| Biomarker and Diagnostic Disclosure | Experimental | 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/-). Receives: Behavioral: Biomarker Disclosure Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study
Measured by attendance at study visits
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start20 Feb 2023
- Primary completion7 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Annalise Rahman-Filipiak, University of Michigan
- Investigators
- Annalise Rahman-Filipiak, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584241
- Sponsor's protocol ID
- HUM00221221
- Other IDs
- 1K23AG070044-01
- Acronym
- SHARED III
- Status last verified
- Aug 2026
- First submitted
- 13 Oct 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Change Following Culturally Informed Biomarker Disclosure in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05584241
- Acronym / sponsor ID
- SHARED III / HUM00221221
- Keywords
- AD Biomarkers, Alzheimer's Disease, Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Disclosure | Active comparator | Behavioral: Diagnostic Disclosure ProtocolPersonalized 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/-). |
| Biomarker and Diagnostic Disclosure | Experimental | Behavioral: Biomarker Disclosure ProtocolParticipants 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/-). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with Amnestic Mild Cognitive Impairment within the past 12 months,
- Available PET Aβ and tau imaging
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Disclosure ProtocolPersonalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling. | Behavioural | Diagnostic Disclosure |
| Biomarker Disclosure ProtocolParticipants 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. | Behavioural | Biomarker and Diagnostic Disclosure |
Primary outcome
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annalise Rahman-Filipiak principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Disclosure Protocol and Biomarker Disclosure Protocol in people with Mild Cognitive Impairment and Alzheimer Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-disclosure health behavior change as measured by the health behavior subscale score (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.