STIM+: PET Biomarker Education & Disclosure

University of Michigan

Status: Completed

Conditions: Mild Cognitive Impairment; Dementia; Alzheimer's Type (Etiology)

Treatments: Behavioral: PET Biomarker Disclosure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04818255

R01AG058724 (U.S. NIH Grant/Contract)

HUM00188109

Details and patient eligibility

About

When dementia is caused by AD, we refer to it as dementia of the Alzheimer's Type (DAT). The greatest risk factor for Alzheimer's Disease (AD) and DAT is advancing age, but DAT is not a normal part of aging. Studies have shown that changes in the brain happen before full symptoms of DAT develop. These changes include a buildup of two proteins within the brain, called amyloid and tau. The two goals of this study are

(1) to determine whether patients with mild cognitive impairment or dementia-Alzheimer's type (DAT) are able to demonstrate decisional capacity to engage in PET amyloid and tau disclosure after receiving education; and (2) to assess how patients and care partners react to PET amyloid and tau biomarker disclosure.

Enrollment: 152 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in the Stimulation to Improve Memory Study (NCT03875326).
• Completed PET scan with amyloid and/or tau tracer success.
• Demonstrates decision-making capacity to engage in PET disclosure, or has a care partner in attendance that demonstrates decision-making capacity for the participant to engage in disclosure
• If diagnosed with DAT: must have a cognitively intact study partner (i.e., their care partner)
• If diagnosed with MCI: strongly recommended to have a cognitively intact study partner (i.e., their care partner)

Exclusion criteria

• Active diagnosis of moderate depression or anxiety without treatment
• Newly diagnosed neurologic disease (since completion of Stimulation to Improve Memory Study activities)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

Disclosure

Experimental group

Description:

Participants who demonstrated decisional capacity for and interest in disclosure (or whose care partner is able to do so) will receive the participant's personalized PET amyloid and tau biomarker status, as well as information about the meaning and clinical utility of this information and recommendations for next steps (e.g., discussing findings with his/her provider).

Treatment:

Behavioral: PET Biomarker Disclosure