STIM+: PET Biomarker Education & Disclosure

Mild Cognitive Impairment Clinical Trial

— STIM+  

Official title:

Stimulation to Improve Memory: PET Education & Disclosure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04818255
• Other study ID #: HUM00188109
• Secondary ID: R01AG058724
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Medical School, Department of Psychiatry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interest in PET Biomarker Disclosure	Percent of individuals surveyed who were interested in receiving their PET biomarker feedback prior to disclosure	At Baseline (at consent session, lasting up to 120 minutes)
Primary	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.	At Baseline (at consent session, lasting up to 120 minutes)
Primary	Change in 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, and 6-weeks post-disclosure
Primary	Change in 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
Primary	Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score	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 from Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure and 6-weeks post-disclosure
Primary	Change in 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.	Change from Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure and 6-weeks post-disclosure
Primary	Change in Stigma Scale for Chronic Illness (SSCI-8) Total Score	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.'	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Primary	Change in Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score	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'.	Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Primary	Change in Future Time Perspectives Scale (FTP) Average Score	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 from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Primary	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, lasting up to 120 minutes.
Primary	Change in Participant Comprehension/Recall of Results Percent Correct Score	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 from immediately following disclosure, 1-week following disclosure, and 6-weeks following disclosure.