STIM+: PET Biomarker Education & Disclosure (STIM+)

Stimulation to Improve Memory: PET Education & Disclosure

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Dementia; Alzheimer's Type (Etiology)
• Intervention / Treatment: Behavioral: PET Biomarker Disclosure

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan Medical School, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Interest in PET Biomarker Disclosure	Percent of participants surveyed who were interested in receiving their PET biomarker feedback following education, prior to disclosure	Immediately Following Pre-Disclosure Education Session (within one month of enrollment)
Percent of Individuals Demonstrating Disclosure Decision-making Capacity	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.	Immediately Following Pre-Disclosure Education Session (within one month of enrollment)
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score	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 from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure (within 6.5 months of baseline), and 6-weeks post-disclosure (within 8 months of baseline)
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score	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 from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score	Measures 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.	Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure (within 6.5 months of baseline), and 6-weeks post-disclosure (within 8 months of baseline)
Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score	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.	Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure (within 6.5 months of baseline), and 6-weeks post-disclosure (within 8 months of baseline)
Effect of Disclosure (Time) and Biomarker Status on Stigma Scale for Chronic Illness (SSCI-8) Total Score	The Stigma Scale for Chronic Illness (SSCI-8) measures perceived and experienced stigma based on a chronic illness (in this case, cognitive disorder). The SSCI-8 demonstrates strong reliability for the measurement of both internalized (perceived) and enacted (experienced) 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'. Items are summed to a total score (min=8, max=40) with higher scores suggesting more stigma.	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Effect of Disclosure (Time) and Biomarker Status on Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score	The Self-Efficacy for Managing Chronic Disease (SECD) scale 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'. Item scores are summed and averaged. Lower scores suggest lower confidence in managing symptoms. Higher scores suggest higher confidence in managing symptoms. There are no clinical cut-offs for this measure.	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Effect of Disclosure (Time) and Biomarker Status on Future Time Perspectives Scale (FTP) Average Score	The Future Time Perspective (FTP) scale is a 10-item scale that 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.' 3 items are reverse scored, then all items are summed and averaged. Minimum average score is 1, maximum average score is 7. Higher scores suggest greater time perspective.	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: Immediately 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.	Immediately following disclosure (within 6 months of baseline)
Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 1-Week Post-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.	1-week post-disclosure (within 6.5 months of baseline)
Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 6-Week Post-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.	6 weeks post-disclosure (within 8 months of baseline)
Preparedness for Caregiving Scale (PCS)	This 8-item measure assesses the degree to which care partners of persons with cognitive impairment (e.g., MCI, DAT) perceive they are prepared for and able to manage various domains of caregiving such as providing physical care and emotional support, setting up in-home support services, and coping with stress due to caregiving. Items use a 5-point likert scale ranging from 0 = 'Not at all prepared' to 4 'Very well prepared'. An average score is generated (min=0, max=4) with higher scores indicating greater preparedness.	Measured at baseline, immediately post-disclosure (within 6 months of baseline), and at 1- (within 6.5 months of baseline) and 6-weeks post-disclosure (within 8 months of baseline)
Revised Scale for Caregiving Self-Efficacy	The Revised Scale for Caregiving Self-Efficacy is a 15-item scale consisting of 3 sub-scales, each containing 5-items, designed to measure perceived ability to manage aspects related to caregiving among caregivers of persons with dementia. Only one subscale was administered in this study: this 5-item subscale is used to measure the co-participant's perceived ability to manage the emotional stresses associated with caregiving. This measure will be administered to study partners only. Items are averaged (min=0, max=100) with higher scores indicating greater perceived confidence to manage the emotional stressed of caregiving.	Measured at baseline, immediately post-disclosure (within 6 months of baseline), and at 1- (within 6.5 months of baseline) and 6-weeks post-disclosure (within 8 months of baseline)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Ben Hampstead, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): November 7, 2024
• Study Completion (Actual): November 7, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: HUM00188109; R01AG058724 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with researchers outside of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No