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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 5/11/26 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/GER-AD DEV | Other Identifier | UW Madison |
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This is a prospective, single-cohort, single-center, observational study to assess if learning one's Alzheimer's disease biomarker test result impacts longitudinal psychosocial, behavioral, and neuropsychological outcomes, and to identify factors that moderate and mediate these outcomes. Participants enrolled in this study are requested to complete surveys at four timepoints after learning their Alzheimer's biomarker test results.
The overall objective is to determine how learning one's amyloid and tau test results impacts longitudinal psychosocial, behavioral, and neuropsychological outcomes, and identify factors that moderate and mediate these outcomes.
The rationale is that by understanding factors that explain variability in reactions, biomarker communication and post-testing support can be tailored to optimize outcomes.
The central hypothesis is that learning biomarker profile will affect psychosocial, behavioral, and neuropsychological outcomes, and that these outcomes will be moderated by social determinants of health (SDOH) and perceived communication factors and mediated by illness perceptions and beliefs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants from UW Alzheimer's Disease Research | Participants aged 50-89 who are cognitively unimpaired or have mild cognitive impairment will be enrolled from the Wisconsin Registry for Alzheimer's Prevention, Wisconsin Alzheimer's Disease Research Center Clinical Core, or other studies affiliated with the UW Alzheimer's Research Program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disclose amyloid, tau results | Other | Release of results from investigational agents conducted under IND 107114, IND 166860, and IND 134516 |
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| Measure | Description | Time Frame |
|---|---|---|
| Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Score | Test-related distress will be assessed using the INI-AD instrument. Score range from 0-80 where higher scores indicate increased negative impact of test. | 1 month, 6 months, 12 months, 18 months |
| Stigma Impact Scale (SIS) Score | Items are rated on a 4-point Likert scale ranging from strongly agree (4) to strongly disagree (1), and a fifth option of "not applicable" with higher total scores (24-96) indicating higher perceived stigma. | 1 month, 6 months, 12 months, 18 months |
| Control, Autonomy, Self-Realization, and Pleasure (CASP-12) | This is a quality of life measure scored from 0-36 where higher scores mean better quality of life. | baseline, 1 month, 6 months, 12 months, 18 months |
| Future Time Perspective Scale | Scores are from 1-7 where higher scores indicate higher engagement. | baseline, 1 month, 6 months, 12 months, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Willingness to Prevent AD | Willingness to seek clinical evaluation about brain health and AD risk will be assessed by the Willingness to Prevent AD Scale, 12 items on a 5-point scale are scored from 12-60 where higher numbers indicate an increased willingness to prevent AD. A sum score (or projected/comparable sum score for participants who complete less than 12 items) for items answered will be calculated as the mean multiplied by the total number of available items, to be comparable between participants who answer a different number of items. |
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Inclusion Criteria:
Exclusion Criteria:
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240 participants aged 50-89 who are cognitively unimpaired or have mild cognitive impairment will be enrolled from the Wisconsin Registry for Alzheimer's Prevention, Wisconsin Alzheimer's Disease Research Center Clinical Core, or other studies affiliated with the UW Alzheimer's Research Program.
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay Clark, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
Data will be stored and shared back with the larger source studies (Wisconsin Registry for Alzheimer's Prevention and Wisconsin Alzheimer's Disease Research Center) to allow for investigators to request the data for future analyses.
De-identified data will be available upon publication of related work or end of the project period, whichever comes first. Data will be preserved for at least five years following the end of the grant period.
De-identified data can be requested by internal and external researchers through data request procedures set by the source studies.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D020774 | Pick Disease of the Brain |
| D003704 | Dementia |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| Follow-up Assessments | Other | self-report psychosocial and behavioral questionnaires |
|
| baseline, 1 month, 6 months, 12 months, 18 months |
| Willingness to Prevent AD: Over the counter, prescription, clinical trial items | Willingness to seek clinical evaluation about brain health and AD risk will also be assessed using 3 additional items added to the instrument, scored on a 5-point scale from 3-15 where higher numbers indicate an increased willingness to prevent AD. | baseline, 1 month, 6 months, 12 months, 18 months |
| Exercise Vital Sign Tool: Minutes per Week of Moderate or Vigorous Exercise | Engagement in health behaviors will in part be assessed using the exercise vital sign tool. This is self-reported as number of days per week and average minutes per day of moderate to vigorous exercise (like a brisk walk). The number of days per week is multiplied by average minutes per day to compute the outcome of minutes per week of moderate or vigorous physical activity. . | baseline, 1 month, 6 months, 12 months, 18 months |
| Cognitive & Leisure Activity Scale (CLAS) | Engagement in health behaviors will in part be assessed by the CLAS scale, scored from 0-80 where higher scores means increased participation in cognitive and leisure activities. | baseline, 1 month, 6 months, 12 months, 18 months |
| 6-item questionnaire for Mediterranean diet | Engagement in health behaviors will in part be assessed with the 6-item questionnaire for Mediterranean diet. Scores range from 0-6 with higher scores more closely resembling a Mediterranean dietary pattern. | baseline, 1 month, 6 months, 12 months, 18 months |
| Brief Pittsburgh Sleep Quality Index (B-PSQI) | Engagement in health behaviors or willingness to engage in brain health behaviors, clinical trials, or treatments will in part be assessed using the B-PSQI, scored from 0-15 where higher scores indicate poorer sleep quality. | baseline, 1 month, 6 months, 12 months, 18 months |
| Number of Participants who Complete Advanced Directives | baseline, 1 month, 6 months, 12 months, 18 months |
| Clinical Trial Enrollment | Clinical trial enrollment will be assessed using an item from the Willingness to Prevent AD survey that inquires about willingness and actual enrollment in clinical trials. Answers include: "will not do", "have not considered", "considered, but have not decided", "ready, will do", and "already did". | baseline, 1 month, 6 months, 12 months, 18 months |
| Communication Assessment Tool (CAT) Score | Communication will be assessed at the 1-month follow-up timepoint using CAT, scored from 15 to 75 where higher scores indicate better reported communication. | 1 month |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D057180 | Frontotemporal Dementia |
| D057174 | Frontotemporal Lobar Degeneration |
| D001519 | Behavior |