Dementia; Alzheimer's Type (Etiology), Mild Cognitive Impairment
Conditions
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.
Interventions
BEHAVIORALPET 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.
Sponsors
University of Michigan
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Disclosure (Time) and Biomarker Status on Future Time Perspectives Scale (FTP) Average Score | 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. |
| Participant Interest in PET Biomarker Disclosure | Immediately Following Pre-Disclosure Education Session (within one month of enrollment) | Percent of participants surveyed who were interested in receiving their PET biomarker feedback following education, prior to disclosure |
| Percent of Individuals Demonstrating Disclosure Decision-making Capacity | Immediately Following Pre-Disclosure Education Session (within one month of enrollment) | 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. |
| Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score | 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. |
| Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score | 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. |
| Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score | 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. |
| Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score | 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. |
| Effect of Disclosure (Time) and Biomarker Status on Stigma Scale for Chronic Illness (SSCI-8) Total Score | 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. |
| Effect of Disclosure (Time) and Biomarker Status on Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score | 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. |
| Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: Immediately Following Disclosure | 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. |
| Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 1-Week Post-Disclosure | 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. |
| Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 6-Week Post-Disclosure | 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. |
| Preparedness for Caregiving Scale (PCS) | 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. |
| Revised Scale for Caregiving Self-Efficacy | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBen Hampstead, PhD
University of Michigan
Participant flow
Recruitment details
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.94 years STANDARD_DEVIATION 7.38 |
| Education | 16.08 years STANDARD_DEVIATION 2.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 135 Participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 18 | 0 / 59 | 0 / 11 |
| other Total, other adverse events | 0 / 60 | 0 / 18 | 0 / 59 | 0 / 11 |
| serious Total, serious adverse events | 0 / 60 | 0 / 18 | 0 / 59 | 0 / 11 |
Outcome results
None listed