Clinical trial NCT04818255: STIM+: PET Biomarker Education & Disclosure
Official title: Stimulation to Improve Memory: PET Education & Disclosure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia; Alzheimer's Type (Etiology)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-03-26
Enrollment: 88
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Interest in PET Biomarker Disclosure
timeFrame: At Baseline (at consent session, lasting up to 120 minutes)
measure: Percent of individuals demonstrating disclosure decision-making capacity
timeFrame: At Baseline (at consent session, lasting up to 120 minutes)
measure: Change in Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score
timeFrame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
measure: Change in Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score
timeFrame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
measure: Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score
timeFrame: Change from Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure and 6-weeks post-disclosure
measure: Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score
timeFrame: Change from Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure and 6-weeks post-disclosure
measure: Change in Stigma Scale for Chronic Illness (SSCI-8) Total Score
timeFrame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
measure: Change in Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score
timeFrame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
measure: Change in Future Time Perspectives Scale (FTP) Average Score
timeFrame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
measure: Participant Comprehension/Recall of Results Percent Correct Score: Immediately Following Disclosure
timeFrame: Immediately following disclosure, lasting up to 120 minutes.
measure: Change in Participant Comprehension/Recall of Results Percent Correct Score
timeFrame: Change from immediately following disclosure, 1-week following disclosure, and 6-weeks following disclosure.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical School, Department of Psychiatry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ben Hampstead, PhD
role: PRINCIPAL_INVESTIGATOR
References: