An observational study in Alzheimer Disease, sponsored by University of Wisconsin, Madison. Enrolling by invitation at 1 site in United States. Open to participants aged 45 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by University of Wisconsin, Madison · Observational
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 240 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Disclose amyloid, tau results · Other: Follow-up Assessments
Release of results from investigational agents conducted under IND 107114, IND 166860, and IND 134516
self-report psychosocial and behavioral questionnaires
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 1 month, 6 months, 12 months, 18 months
Future Time Perspective Scale
Scores are from 1-7 where higher scores indicate higher engagement.
Time frame: baseline, 1 month, 6 months, 12 months, 18 months
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.
Time frame: 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.
Time frame: 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. .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 1 month, 6 months, 12 months, 18 months
Number of Participants who Complete Advanced Directives
Time frame: 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".
Time frame: 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.
Time frame: 1 month
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 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.
Access criteria: De-identified data can be requested by internal and external researchers through data request procedures set by the source studies.
Data sharing details ↗ · wrap.wisc.edu
No publications or documents are linked to this record.
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