100 Participants Needed

Biomarker Disclosure for Alzheimer's Disease

(SHARED III Trial)

AR
Overseen ByAnnalise Rahman-Filipiak
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12345

Who Is on the Research Team?

AR

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
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Biomarker and Diagnostic DisclosureExperimental Treatment1 Intervention
Group II: Diagnostic DisclosureActive Control1 Intervention

Find a Clinic Near You

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

The importance of the dyad: Participant perspectives on sharing biomarker results in Alzheimer's disease research. [2023]
Moving beyond disclosure: Stages of care in preclinical Alzheimer's disease biomarker testing. [2023]
Perspectives From Black and White Participants and Care Partners on Return of Amyloid and Tau PET Imaging and Other Research Results. [2023]
Testing for Alzheimer Disease Biomarkers and Disclosing Results Across the Disease Continuum. [2023]
Biomarker disclosure protocols in prodromal Alzheimer's disease clinical trials. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security