N/A N=148 Health Services Research

STIM+: PET Biomarker Education & Disclosure

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

Bottom Line

View on ClinicalTrials.gov: NCT04818255 ↗

Enrolled (actual)

148

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcome: Primary: Participant Interest in PET Biomarker Disclosure — 73 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PET Biomarker Disclosure (Behavioral)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Participant Interest in PET Biomarker Disclosure	73	—
PRIMARY Percent of Individuals Demonstrating Disclosure Decision-making Capacity	25; 10	<.001 sig
PRIMARY Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score	38.53; 36.19; 39.49; 40.63; 35.10; 37.31	.146
PRIMARY Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score	15.10; 13.31; 15.47; 16.88; 14.71; 14.50	.094
PRIMARY Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score	12.15; 1.87; 11.84; 1.50; 11.90; 2.47	<.001 sig
PRIMARY Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score	12.17; 17.93; 11.27; 19.00; 10.87; 17.40	<.001 sig
PRIMARY Effect of Disclosure (Time) and Biomarker Status on Stigma Scale for Chronic Illness (SSCI-8) Total Score	11.14; 9.63; 9.86; 10.31; 10.50; 9.56	.051
PRIMARY Effect of Disclosure (Time) and Biomarker Status on Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score	7.96; 8.10; 7.94; 8.21; 7.32; 8.32	.399
PRIMARY Effect of Disclosure (Time) and Biomarker Status on Future Time Perspectives Scale (FTP) Average Score	4.33; 5.00; 4.68; 5.24; 4.42; 4.91	.615
PRIMARY Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: Immediately Following Disclosure	93.25; 72.27; 98.26; 94.95	<.001 sig
PRIMARY Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 1-Week Post-Disclosure	86.38; 64.22; 98.80; 98.39	<.001 sig
PRIMARY Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 6-Week Post-Disclosure	87.79; 62.47; 98.90; 96.77	<.001 sig
PRIMARY Preparedness for Caregiving Scale (PCS)	2.95; 3.52; 3.06; 3.66; 3.07; 3.53	.835
PRIMARY Revised Scale for Caregiving Self-Efficacy	81.69; 83.88; 80.55; 94.88; 81.26; 86.10	.037 sig

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04818255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.