STIM+: PET Biomarker Education & Disclosure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2024-11-07

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants and care partners who demonstrate intact decisional capacity to engage in PET biomarker disclosure, and who wish to receive the participant's PET results will be provided with education, results, and recommendations for next steps and supportive resources (the intervention). After this intervention, participants will complete follow-up evaluations of mood and anxiety within one week and at six weeks post disclosure.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Disclosure

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).

Group Type EXPERIMENTAL

PET Biomarker Disclosure

Intervention Type BEHAVIORAL

Participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging conducted as part of an affiliated research study (no additional imaging is required for this project). Participants meet with a licensed clinical neuropsychologist to discuss their biomarker status, the meaning of this information, and potential next steps to consider based of their status. Participants receive written summaries of this information, as well as resources as deemed necessary or as requested.

Interventions

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PET Biomarker Disclosure

Participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging conducted as part of an affiliated research study (no additional imaging is required for this project). Participants meet with a licensed clinical neuropsychologist to discuss their biomarker status, the meaning of this information, and potential next steps to consider based of their status. Participants receive written summaries of this information, as well as resources as deemed necessary or as requested.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No