Biomarker Disclosure for Alzheimer's Disease
(SHARED III Trial)
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.12345
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.56789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Diagnostic Disclosure
Participants receive personalized disclosure on cognitive test results and research diagnosis, followed by post-disclosure dementia risk reduction counseling
Follow-up
Participants are monitored for health behavior changes and research engagement post-disclosure
Long-term Follow-up
Participants' retention in the University of Michigan Memory and Aging Project is measured
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?
2
Treatment groups
Experimental Treatment
Active Control
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/-).
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/-).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Citations
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 ...
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 ...
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alz-journals.onlinelibrary.wiley.com
alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.14365Counseling 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.
Research Participant Interest in Results of Biomarker Tests ...
This cohort study quantitatively and qualitatively assesses research participants' decision to learn individual Alzheimer disease biomarker ...
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 ...
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.
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.
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.
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 ...
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