Trial Outcomes & Findings for STIM+: PET Biomarker Education & Disclosure (NCT NCT04818255)

NCT ID: NCT04818255

Last Updated: 2026-01-29

Results Overview

Percent of participants surveyed who were interested in receiving their PET biomarker feedback following education, prior to disclosure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 152 participants
• Primary outcome timeframe: Immediately Following Pre-Disclosure Education Session (within one month of enrollment)
• Results posted on: 2026-01-29

Participant Flow

161 total individuals were recruited for the study; however, 9 screen failed during the screening and consenting process and were not eligible to begin study activities

Participant milestones

Measure	Amyloid Positive Participants Participants with amyloid positivity (amyloid positive, tau positive and amyloid positive, tau negative).	Amyloid Negative Participants Participants with negative amyloid results (amyloid negative, tau negative and amyloid negative, tau unknown; no participants had amyloid negative, tau positive results)	Study Partners of Amyloid Positive Participants Study partners of participants later found to have amyloid positivity	Study Partners of Amyloid Negative Participants Study partners of participants later found to be amyloid negative
Education Session STARTED	60	18	59	11
Education Session COMPLETED	60	18	59	11
Education Session NOT COMPLETED	0	0	0	0
Disclosure Sesions STARTED	55	16	55	8
Disclosure Sesions COMPLETED	54	16	54	8
Disclosure Sesions NOT COMPLETED	1	0	1	0

Reasons for withdrawal

Measure	Amyloid Positive Participants Participants with amyloid positivity (amyloid positive, tau positive and amyloid positive, tau negative).	Amyloid Negative Participants Participants with negative amyloid results (amyloid negative, tau negative and amyloid negative, tau unknown; no participants had amyloid negative, tau positive results)	Study Partners of Amyloid Positive Participants Study partners of participants later found to have amyloid positivity	Study Partners of Amyloid Negative Participants Study partners of participants later found to be amyloid negative
Disclosure Sesions Lost to Follow-up	1	0	1	0

Baseline Characteristics

Missing age data for 1 study partner

Baseline characteristics by cohort

Measure	Amyloid Positive Participants n=62 Participants Participants with amyloid positivity (amyloid positive, tau positive and amyloid positive, tau negative).	Amyloid Negative Participants n=18 Participants Participants with negative amyloid results (amyloid negative, tau negative and amyloid negative, tau unknown; no participants had amyloid negative, tau positive results)	Study Partners of Amyloid Positive Participants n=61 Participants Study partners of participants later found to be amyloid positive	Study Partners of Amyloid Negative Participants n=11 Participants Study partners of participants later found to be amyloid negative	Total n=152 Participants Total of all reporting groups
Age, Continuous	71.55 years STANDARD_DEVIATION 7.07 • n=62 Participants • Missing age data for 1 study partner	71.94 years STANDARD_DEVIATION 7.38 • n=18 Participants • Missing age data for 1 study partner	67.10 years STANDARD_DEVIATION 8.96 • n=60 Participants • Missing age data for 1 study partner	71.09 years STANDARD_DEVIATION 9.03 • n=11 Participants • Missing age data for 1 study partner	71.64 years STANDARD_DEVIATION 7.10 • n=151 Participants • Missing age data for 1 study partner
Sex: Female, Male Female	33 Participants n=62 Participants	7 Participants n=18 Participants	37 Participants n=61 Participants	6 Participants n=11 Participants	83 Participants n=152 Participants
Sex: Female, Male Male	29 Participants n=62 Participants	11 Participants n=18 Participants	24 Participants n=61 Participants	5 Participants n=11 Participants	69 Participants n=152 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=62 Participants	0 Participants n=18 Participants	0 Participants n=61 Participants	0 Participants n=11 Participants	0 Participants n=152 Participants
Race (NIH/OMB) Asian	0 Participants n=62 Participants	0 Participants n=18 Participants	1 Participants n=61 Participants	1 Participants n=11 Participants	2 Participants n=152 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=62 Participants	0 Participants n=18 Participants	0 Participants n=61 Participants	0 Participants n=11 Participants	0 Participants n=152 Participants
Race (NIH/OMB) Black or African American	3 Participants n=62 Participants	3 Participants n=18 Participants	2 Participants n=61 Participants	2 Participants n=11 Participants	10 Participants n=152 Participants
Race (NIH/OMB) White	59 Participants n=62 Participants	12 Participants n=18 Participants	58 Participants n=61 Participants	6 Participants n=11 Participants	135 Participants n=152 Participants
Race (NIH/OMB) More than one race	0 Participants n=62 Participants	0 Participants n=18 Participants	0 Participants n=61 Participants	1 Participants n=11 Participants	1 Participants n=152 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=62 Participants	3 Participants n=18 Participants	0 Participants n=61 Participants	1 Participants n=11 Participants	4 Participants n=152 Participants
Education	16.08 years STANDARD_DEVIATION 2.54 • n=61 Participants • Education data were missing for 1 participant and 3 study partners	15.89 years STANDARD_DEVIATION 3.10 • n=18 Participants • Education data were missing for 1 participant and 3 study partners	16.24 years STANDARD_DEVIATION 2.90 • n=59 Participants • Education data were missing for 1 participant and 3 study partners	16.00 years STANDARD_DEVIATION 2.49 • n=10 Participants • Education data were missing for 1 participant and 3 study partners	16.04 years STANDARD_DEVIATION 2.66 • n=148 Participants • Education data were missing for 1 participant and 3 study partners

PRIMARY outcome

Timeframe: Immediately Following Pre-Disclosure Education Session (within one month of enrollment)

Population: Only participants were surveyed on their interest in learning biomarker results. At the time of this outcome measure, neither participants nor study team knew the participants' amyloid status; therefore, this outcome was designed to be measured independent of biomarker status.

Percent of participants surveyed who were interested in receiving their PET biomarker feedback following education, prior to disclosure

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=78 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants Study Partners of Participants found to be amyloid negative
Participant Interest in PET Biomarker Disclosure	73 Participants	—	—	—

PRIMARY outcome

Timeframe: Immediately Following Pre-Disclosure Education Session (within one month of enrollment)

Population: Decision-making capacity was only measured in participants (not study partners) for the purpose of this aim. The aim also investigated differences in decision-making capacity for biomarker disclosure based on diagnosis (MCI vs. Dementia). At the time that this outcome was assessed, neither participants nor study team knew the participants' biomarker status. Therefore, decision-making capacity was compared only by participant diagnostic group.

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=32 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=46 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants Study Partners of Participants found to be amyloid negative
Percent of Individuals Demonstrating Disclosure Decision-making Capacity	25 Participants	10 Participants	—	—

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=51 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=16 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants n=49 Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants n=8 Participants Study Partners of Participants found to be amyloid negative
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score Baseline	38.53 PANAS Positive subscale score Standard Deviation 5.78	36.19 PANAS Positive subscale score Standard Deviation 7.05	39.49 PANAS Positive subscale score Standard Deviation 5.76	40.63 PANAS Positive subscale score Standard Deviation 6.39
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score Immediate Post-Disclosure	35.10 PANAS Positive subscale score Standard Deviation 6.77	37.31 PANAS Positive subscale score Standard Deviation 7.13	37.61 PANAS Positive subscale score Standard Deviation 6.75	41.13 PANAS Positive subscale score Standard Deviation 7.06
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score 1-Week Post-Disclosure	35.31 PANAS Positive subscale score Standard Deviation 8.34	36.81 PANAS Positive subscale score Standard Deviation 9.03	38.27 PANAS Positive subscale score Standard Deviation 6.87	42.25 PANAS Positive subscale score Standard Deviation 5.42
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score 6-Week Post-Disclosure	36.10 PANAS Positive subscale score Standard Deviation 7.43	36.50 PANAS Positive subscale score Standard Deviation 10.45	38.35 PANAS Positive subscale score Standard Deviation 7.12	41.13 PANAS Positive subscale score Standard Deviation 6.03

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=51 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=16 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants n=49 Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants n=8 Participants Study Partners of Participants found to be amyloid negative
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score 1-Week Post-Disclosure	16.22 PANAS Negative Subscale Score Standard Deviation 6.87	13.31 PANAS Negative Subscale Score Standard Deviation 3.54	14.86 PANAS Negative Subscale Score Standard Deviation 4.70	14.75 PANAS Negative Subscale Score Standard Deviation 4.62
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score Pre-Disclosure	15.10 PANAS Negative Subscale Score Standard Deviation 5.16	13.31 PANAS Negative Subscale Score Standard Deviation 4.95	15.47 PANAS Negative Subscale Score Standard Deviation 4.92	16.88 PANAS Negative Subscale Score Standard Deviation 9.60
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score Immediately Post-Disclosure	14.71 PANAS Negative Subscale Score Standard Deviation 5.33	14.50 PANAS Negative Subscale Score Standard Deviation 3.92	14.73 PANAS Negative Subscale Score Standard Deviation 3.97	16.38 PANAS Negative Subscale Score Standard Deviation 5.55
Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score 6-Week Post-Disclosure	15.08 PANAS Negative Subscale Score Standard Deviation 5.23	14.56 PANAS Negative Subscale Score Standard Deviation 4.75	14.90 PANAS Negative Subscale Score Standard Deviation 5.06	15.63 PANAS Negative Subscale Score Standard Deviation 6.93

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=52 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=15 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants n=51 Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants n=8 Participants Study Partners of Participants found to be amyloid negative
Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score Immediately Post-Disclosure	12.15 INI-AD Distress Subscale Total Score Standard Deviation 10.01	1.87 INI-AD Distress Subscale Total Score Standard Deviation 2.23	11.84 INI-AD Distress Subscale Total Score Standard Deviation 7.42	1.50 INI-AD Distress Subscale Total Score Standard Deviation 2.50
Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score 1-Week Post-Disclosure	11.90 INI-AD Distress Subscale Total Score Standard Deviation 10.62	2.47 INI-AD Distress Subscale Total Score Standard Deviation 5.21	11.86 INI-AD Distress Subscale Total Score Standard Deviation 6.59	4.13 INI-AD Distress Subscale Total Score Standard Deviation 4.52
Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score 6-Weeks Post-Disclosure	10.44 INI-AD Distress Subscale Total Score Standard Deviation 9.09	1.93 INI-AD Distress Subscale Total Score Standard Deviation 3.11	12.06 INI-AD Distress Subscale Total Score Standard Deviation 6.60	3.50 INI-AD Distress Subscale Total Score Standard Deviation 5.21

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=52 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=15 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants n=51 Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants n=8 Participants Study Partners of Participants found to be amyloid negative
Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score Immediately Post-Disclosure	12.17 INI-AD Positive Subscale Total Score Standard Deviation 3.47	17.93 INI-AD Positive Subscale Total Score Standard Deviation 3.77	11.27 INI-AD Positive Subscale Total Score Standard Deviation 3.78	19.00 INI-AD Positive Subscale Total Score Standard Deviation 2.14
Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score 1-Week Post-Disclosure	10.87 INI-AD Positive Subscale Total Score Standard Deviation 4.14	17.40 INI-AD Positive Subscale Total Score Standard Deviation 3.33	10.82 INI-AD Positive Subscale Total Score Standard Deviation 3.01	18.50 INI-AD Positive Subscale Total Score Standard Deviation 1.77
Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score 6-Weeks Post-Disclosure	11.04 INI-AD Positive Subscale Total Score Standard Deviation 12.25	3.53 INI-AD Positive Subscale Total Score Standard Deviation 4.57	10.25 INI-AD Positive Subscale Total Score Standard Deviation 2.46	17.75 INI-AD Positive Subscale Total Score Standard Deviation 3.11

PRIMARY outcome

Timeframe: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=50 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=16 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants Study Partners of Participants found to be amyloid negative
Effect of Disclosure (Time) and Biomarker Status on Stigma Scale for Chronic Illness (SSCI-8) Total Score Baseline (Pre-Disclosure)	11.14 SSCI-8 Total Score Standard Deviation 2.86	9.63 SSCI-8 Total Score Standard Deviation 2.06	—	—
Effect of Disclosure (Time) and Biomarker Status on Stigma Scale for Chronic Illness (SSCI-8) Total Score Immediately Post-Disclosure	9.86 SSCI-8 Total Score Standard Deviation 2.20	10.31 SSCI-8 Total Score Standard Deviation 2.75	—	—
Effect of Disclosure (Time) and Biomarker Status on Stigma Scale for Chronic Illness (SSCI-8) Total Score 1-Week Post-Disclosure	10.50 SSCI-8 Total Score Standard Deviation 2.89	9.56 SSCI-8 Total Score Standard Deviation 1.90	—	—
Effect of Disclosure (Time) and Biomarker Status on Stigma Scale for Chronic Illness (SSCI-8) Total Score 6-Weeks Post-Disclosure	10.02 SSCI-8 Total Score Standard Deviation 2.77	9.69 SSCI-8 Total Score Standard Deviation 2.33	—	—

PRIMARY outcome

Timeframe: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=51 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=16 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants Study Partners of Participants found to be amyloid negative
Effect of Disclosure (Time) and Biomarker Status on Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score Baseline (Pre-Disclosure)	7.96 SECD Total Score Standard Deviation 1.73	8.10 SECD Total Score Standard Deviation 1.24	—	—
Effect of Disclosure (Time) and Biomarker Status on Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score Immediately Post-Disclosure	7.94 SECD Total Score Standard Deviation 1.47	8.21 SECD Total Score Standard Deviation 1.39	—	—
Effect of Disclosure (Time) and Biomarker Status on Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score 1-Week Post-Disclosure	7.32 SECD Total Score Standard Deviation 2.11	8.32 SECD Total Score Standard Deviation 2.22	—	—
Effect of Disclosure (Time) and Biomarker Status on Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score 6-Week Post-Disclosure	7.48 SECD Total Score Standard Deviation 1.90	8.06 SECD Total Score Standard Deviation 1.79	—	—

PRIMARY outcome

Timeframe: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=51 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=16 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants n=49 Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants n=8 Participants Study Partners of Participants found to be amyloid negative
Effect of Disclosure (Time) and Biomarker Status on Future Time Perspectives Scale (FTP) Average Score Immediately Post-Disclosure	4.42 FTP Total Score Standard Deviation 1.13	4.91 FTP Total Score Standard Deviation 1.03	4.56 FTP Total Score Standard Deviation 1.14	5.20 FTP Total Score Standard Deviation 1.06
Effect of Disclosure (Time) and Biomarker Status on Future Time Perspectives Scale (FTP) Average Score Baseline (Pre-Disclosure)	4.33 FTP Total Score Standard Deviation 1.10	5.00 FTP Total Score Standard Deviation 0.86	4.68 FTP Total Score Standard Deviation 1.11	5.24 FTP Total Score Standard Deviation 0.76
Effect of Disclosure (Time) and Biomarker Status on Future Time Perspectives Scale (FTP) Average Score 1-Week Post-Disclosure	4.35 FTP Total Score Standard Deviation 1.29	4.77 FTP Total Score Standard Deviation 1.12	4.52 FTP Total Score Standard Deviation 1.03	5.20 FTP Total Score Standard Deviation 1.07
Effect of Disclosure (Time) and Biomarker Status on Future Time Perspectives Scale (FTP) Average Score 6-Weeks Post-Disclosure	4.23 FTP Total Score Standard Deviation 1.22	4.52 FTP Total Score Standard Deviation 1.08	4.40 FTP Total Score Standard Deviation 1.00	5.09 FTP Total Score Standard Deviation 1.00

PRIMARY outcome

Timeframe: Immediately following disclosure (within 6 months of baseline)

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=28 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=39 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants n=19 Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants n=37 Participants Study Partners of Participants found to be amyloid negative
Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: Immediately Following Disclosure	93.25 % correct on comprehension measure Standard Deviation 16.09	72.27 % correct on comprehension measure Standard Deviation 23.92	98.26 % correct on comprehension measure Standard Deviation 5.52	94.95 % correct on comprehension measure Standard Deviation 16.17

PRIMARY outcome

Timeframe: 1-week post-disclosure (within 6.5 months of baseline)

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=29 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=41 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants n=20 Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants n=41 Participants Study Partners of Participants found to be amyloid negative
Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 1-Week Post-Disclosure	86.38 Percent Correct Standard Deviation 21.25	64.22 Percent Correct Standard Deviation 30.30	98.80 Percent Correct Standard Deviation 3.71	98.39 Percent Correct Standard Deviation 5.80

PRIMARY outcome

Timeframe: 6 weeks post-disclosure (within 8 months of baseline)

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=29 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=39 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants n=20 Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants n=39 Participants Study Partners of Participants found to be amyloid negative
Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 6-Week Post-Disclosure	87.79 Percent Correct Standard Deviation 18.06	62.47 Percent Correct Standard Deviation 29.10	98.90 Percent Correct Standard Deviation 4.92	96.77 Percent Correct Standard Deviation 8.77

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=47 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=8 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants Study Partners of Participants found to be amyloid negative
Preparedness for Caregiving Scale (PCS) Baseline	2.95 PCS total score Standard Deviation 0.62	3.52 PCS total score Standard Deviation 0.49	—	—
Preparedness for Caregiving Scale (PCS) Immediately Post-Disclosure	3.06 PCS total score Standard Deviation 0.58	3.66 PCS total score Standard Deviation 0.45	—	—
Preparedness for Caregiving Scale (PCS) 1-Week Post-Disclosure	3.07 PCS total score Standard Deviation 0.66	3.53 PCS total score Standard Deviation 0.53	—	—
Preparedness for Caregiving Scale (PCS) 6-Weeks Post-Disclosure	3.01 PCS total score Standard Deviation 0.69	3.51 PCS total score Standard Deviation 0.58	—	—

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	Participants Who Completed the Pre-disclosure Educational Session n=47 Participants Participants who completed consent and the pre-disclosure education and decision-making assessment session	Dementia n=8 Participants Participants diagnosed with dementia presumed to be of the Alzheimer's type	Study Partners of Amyloid Positive Participants Study Partners of Participants found to be amyloid positive	Study Partners of Amyloid Negative Participants Study Partners of Participants found to be amyloid negative
Revised Scale for Caregiving Self-Efficacy Baseline	81.69 total subscale score Standard Deviation 13.62	83.88 total subscale score Standard Deviation 15.01	—	—
Revised Scale for Caregiving Self-Efficacy Immediately Post-Disclosure	80.55 total subscale score Standard Deviation 14.25	94.88 total subscale score Standard Deviation 5.25	—	—
Revised Scale for Caregiving Self-Efficacy 1-Week Post-Disclosure	81.26 total subscale score Standard Deviation 14.44	86.10 total subscale score Standard Deviation 10.50	—	—
Revised Scale for Caregiving Self-Efficacy 6-Weeks Post-Disclosure	77.76 total subscale score Standard Deviation 15.59	88.83 total subscale score Standard Deviation 7.93	—	—

Adverse Events

Amyloid Positive Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Amyloid Negative Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Study Partners of Amyloid Positive Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Study Partners of Amyloid Negative Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Annalise Rahman-Filipiak

University of Michigan

Phone: 7349363180

Email: rahmanam@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place