Biomarker Disclosure for Alzheimer's Disease

(SHARED III Trial)

Overseen By Annalise Rahman-Filipiak

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Alzheimer's, Parkinson's, Stroke, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Biomarker Disclosure Protocol and Diagnostic Disclosure Protocol treatment for Alzheimer's disease?

The research suggests that disclosing biomarker information in Alzheimer's disease can have psychosocial benefits and is informed by experiences from similar conditions like Huntington's disease. This approach involves careful pre-disclosure education, consent, and follow-up to support well-being, indicating potential effectiveness in managing the emotional and psychological impact of the information. ^{1 2 3 4 5}

How does this treatment differ from other Alzheimer's disease treatments?

This treatment is unique because it focuses on disclosing biomarker information, which can indicate the risk of developing Alzheimer's disease before symptoms appear. Unlike traditional treatments that address symptoms, this approach aims to inform patients and their support networks early, potentially allowing for better planning and management of the disease. ^{1 2 3 4 5}

Research Team

Annalise Rahman-Filipiak

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for Black and White patients recently diagnosed with Amnestic Mild Cognitive Impairment (aMCI) who have undergone PET scans showing amyloid and tau proteins. It's not suitable for those with severe neurological diagnoses, significant neurologic injury, motor abnormalities not due to AD, severe mental illness, or active substance use disorders.

Inclusion Criteria

Available PET Aβ and tau imaging

I was diagnosed with memory loss affecting my daily life within the last year.

Exclusion Criteria

I do not have major neurological conditions like Alzheimer's, Parkinson's, seizures, tumors, or MS.

I cannot give consent on my own due to my condition.

Motor abnormalities indicative of a non-AD etiology

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Disclosure

Participants receive personalized disclosure on cognitive test results and research diagnosis, followed by post-disclosure dementia risk reduction counseling

1-2 weeks

Follow-up

Participants are monitored for health behavior changes and research engagement post-disclosure

6 months

Long-term Follow-up

Participants' retention in the University of Michigan Memory and Aging Project is measured

Up to 24 months

Treatment Details

Interventions

• Biomarker Disclosure Protocol
• Diagnostic Disclosure Protocol

Trial Overview The study examines the impact of informing participants about their brain imaging results that show markers of Alzheimer's disease. It looks at how this knowledge might change their health behaviors, planning for the future, and willingness to participate in research.

Participant Groups

Group I: Biomarker and Diagnostic Disclosure Experimental Treatment 1 Intervention

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/-).

Group II: Diagnostic Disclosure Active Control 1 Intervention

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/-).

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The importance of the dyad: Participant perspectives on sharing biomarker results in Alzheimer's disease research. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Moving beyond disclosure: Stages of care in preclinical Alzheimer's disease biomarker testing. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Perspectives From Black and White Participants and Care Partners on Return of Amyloid and Tau PET Imaging and Other Research Results. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Testing for Alzheimer Disease Biomarkers and Disclosing Results Across the Disease Continuum. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Biomarker disclosure protocols in prodromal Alzheimer's disease clinical trials. [2023]