STIM+: PET Biomarker Education & Disclosure

Not Applicable

• Conditions: Dementia; Alzheimer's Type (Etiology); Mild Cognitive Impairment
• Interventions: Behavioral: PET Biomarker Disclosure

• Registration Number: NCT04818255
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Disclosure	PET Biomarker 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).

Primary Outcome Measures

Name	Time	Method
Change in Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure	This 10-item subscale asks respondents to rate the extent to which they are experiencing positive negative (e.g., distressed, ashamed) emotions on a Likert-style scale ranging from '1 = Very Slightly or Not at All' to '5=Extremely.' The scores range from 10-50, with higher scores indicating higher negative emotions.
Change in Future Time Perspectives Scale (FTP) Average Score	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure	This 10-item scale measures the extent to which respondents feel that they have potential for productive and functional years ahead of them. Statements regarding positive and negative future time perspective are rated on a 7-point Likert-style scale, ranging from 1= 'Very untrue' to 7='Very true.'
Change in Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure	The SECD is a 6-item scale that measures perceived ability to self-manage the physical, emotional, and cognitive symptoms associated with their chronic disease. Items are listed on a 10-point scale ranging from 1 = 'Not at all confident' to 10 = 'Totally confident'.
Percent of individuals demonstrating disclosure decision-making capacity	At Baseline (at consent session, lasting up to 120 minutes)	This interactive interview involves an assessment of understanding, appreciation, rationale, and communication of a decision regarding participating or not participating in PET biomarker disclosure. During an education session in which information about PET disclosure is reviewed, participants are asked questions to determine how well they comprehend and appreciated risks and benefits of engaging in PET biomarker disclosure. They are provided with prompts/clarification as needed. Examiners subjectively score each response as correct or incorrect and utilize this information to determine whether participants are demonstrate decisional capacity for PET biomarker disclosure. Results are pass (disclosure decisional capacity intact) or fail (disclosure decisional capacity not intact). Therefore, we will measure the percent of individuals who are able to pass this measure.
Change in Stigma Scale for Chronic Illness (SSCI-8) Total Score	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure	The SSCI-8 demonstrates strong reliability for the measurement of both internalized and enacted stigma perceived by individuals with chronic neurological conditions. Respondents complete 8 items about experiences of stigma, rated on a Likert-style scale from 1 = 'Never' to 5 = 'Always.'
Participant Comprehension/Recall of Results Percent Correct Score: Immediately Following Disclosure	Immediately following disclosure, lasting up to 120 minutes.	This tool, created for the purpose of this study, measures participant's ability to understand their biomarker results and their meaning. Scores on the nine items are converted into a percent correct score, with higher scores indicating better comprehension and memory of results.
Interest in PET Biomarker Disclosure	At Baseline (at consent session, lasting up to 120 minutes)	Percent of individuals surveyed who were interested in receiving their PET biomarker feedback prior to disclosure
Change in Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure	This 10-item subscale asks respondents to rate the extent to which they are experiencing positive (e.g., excited, inspired) emotions on a Likert-style scale ranging from '1 = Very Slightly or Not at All' to '5=Extremely.' Scores range from 10-50, with higher scores indicating higher positive emotions.
Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score	Change from Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure and 6-weeks post-disclosure	Measures change in negative reactions to AD-related personal neuroimaging results received as part of disclosure (0-55; higher scores indicate higher distress) starting from immediately following disclosure to six weeks post-disclosure.
Change in Participant Comprehension/Recall of Results Percent Correct Score	Change from immediately following disclosure, 1-week following disclosure, and 6-weeks following disclosure.	This tool, created for the purpose of this study, measures participant's ability to understand their biomarker results and their meaning. Scores on the nine items are converted into a percent correct score, with higher scores indicating better comprehension and memory of results.
Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score	Change from Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure and 6-weeks post-disclosure	Measures change in positive reactions to AD-related personal neuroimaging results received as part of disclosure (0-20; higher scores indicate higher positive emotions) starting from immediately following disclosure to six weeks post-disclosure.

Trial Locations

Locations (1)

University of Michigan Medical School, Department of Psychiatry; 🇺🇸 Ann Arbor, Michigan, United States