Biomarker Disclosure for Alzheimer's Disease
(SHARED III Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAnnalise Rahman-Filipiak

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

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.

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

+2 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Biomarker and Diagnostic DisclosureExperimental Treatment1 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 DisclosureActive Control1 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/-).