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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how learning about certain brain markers affects people with aMCI, a mild memory problem that could lead to Alzheimer's. Participants will receive information from brain scans about amyloid and tau, proteins linked to Alzheimer's, and receive advice on reducing dementia risk. The study seeks to determine how this information might change health habits and planning. It is suitable for individuals diagnosed with aMCI in the past year who have specific PET scan results available. As an unphased trial, this study offers a unique opportunity to gain valuable insights into personal brain health and potentially improve future care strategies.

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 prior data suggests that these protocols are safe?

Studies have shown that sharing test results related to Alzheimer's can be safe and helpful. For example, knowing their risk or test results can help people make informed health and lifestyle choices. Research indicates that sharing this information can increase confidence in a diagnosis and provide benefits like personalized counseling. Overall, this approach is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Biomarker Disclosure Protocol and Diagnostic Disclosure Protocol for Alzheimer's Disease because they offer a new way to personalize patient care. Unlike standard treatments that focus on symptom management, these protocols provide patients with detailed information about their cognitive health and biomarker status, specifically amyloid and tau levels, which are crucial in Alzheimer's diagnosis. This personalized approach could empower patients with a clearer understanding of their condition and guide them in making informed decisions about their health, potentially optimizing dementia risk reduction strategies.

What evidence suggests that this trial's protocols could be effective for Alzheimer's disease?

Research has shown that sharing information about Alzheimer's disease markers can be done safely and may help people make important health decisions. In this trial, participants in the "Diagnostic Disclosure" arm will receive personalized disclosure of cognitive test results and research diagnosis, along with post-disclosure dementia risk reduction counseling. Participants in the "Biomarker and Diagnostic Disclosure" arm will receive additional information about their amyloid and tau levels based on PET imaging. Studies have found that learning about marker results helps people understand and plan for their future health needs. Knowing one's risk from a PET scan can also help people take steps to lower their chances of developing Alzheimer's disease. Previous findings suggest that receiving this information, along with counseling, reduces stress while keeping people informed. This approach aims to empower individuals by providing them with knowledge about their health and potential risks. ^{5 6 7 8 9}

Who Is on the Research Team?

Annalise Rahman-Filipiak

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12501330/

Disclosure of Alzheimer's disease blood-based biomarker ... Available data suggests that disclosure of AD risk or biomarker test results can be performed safely and have numerous benefits. In research ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11573811/

Informing Alzheimer's Biomarker Communication Prior studies on disclosure of AD biomarkers highlight three primary goals: minimize psychological distress; ensure individuals are informed about their results ...

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.14365

Counseling and disclosure practices in predictive Alzheimer's ... Disclosure of preclinical Alzheimer's disease biomarker results in research and clinical settings: why, how, and what we still need to know.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833583

Research Participant Interest in Results of Biomarker Tests ... This cohort study quantitatively and qualitatively assesses research participants' decision to learn individual Alzheimer disease biomarker ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724000761

A Pragmatic, Investigator-Driven Process for Disclosure of ... This article describes the process developed for ADNI amyloid PET disclosure, which may be informative for other studies developing AD biomarker disclosure ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10530125/

Biomarker disclosure protocols in prodromal Alzheimer's ... In contrast, biomarker results shared with providers may support diagnostic confidence, and personalized health and lifestyle change for participants.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2274580725002535

Disclosure of Alzheimer's disease blood-based biomarker ... Available data suggests that disclosure of AD risk or biomarker test results can be performed safely and have numerous benefits.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10238153/

Testing for Alzheimer Disease Biomarkers and Disclosing ... We propose a 5-step approach informed by clinical and research experience designing and implementing AD biomarker disclosure processes.

9. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12463

Personal value of Alzheimer's disease biomarker testing and ... Biomarker result disclosure enabled care partners to recognize the need for caregiver-specific support, and many valued the ability to involve ...