Learning Amyloid and Tau Results

Reactions to Learning Amyloid and Tau Results in Adults at Risk for Alzheimer's Dementia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: Disclose amyloid, tau results; Other: Follow-up Assessments

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Willing to provide informed consent.
• Willing to comply with all study procedures and be available for the duration of the study.
• Individuals at least 50 years of age.
• Enrolled in Wisconsin Registry for Alzheimer's Prevention (WRAP) or Alzheimer's Disease Research Center Clinical Core (ADRC)
• Previously adjudicated as cognitively unimpaired having mild cognitive impairment (MCI), or impaired but do not meet diagnostic criteria for mild cognitive impairment or dementia (classified as "Impaired-Not MCI" by the WRAP and ADRC cohorts) at their last WRAP or ADRC study visit at the time of enrollment into this study
• Have completed or able to complete amyloid and/or tau PET scans as part of a UW Alzheimer's Research Study

Exclusion Criteria:

• Diagnosis of dementia at the time of enrollment as determined by the most recent parent WRAP/ADRC study visit diagnostic consensus conference using standard NIA-AA 2011 diagnostic criteria. Participants who develop dementia after enrolling into this study may remain enrolled if they maintain decisional capacity and are able to follow study instructions and procedures.
• Individuals who lack decisional capacity to provide informed consent as determined by significant difficulty in understanding materials and information about study procedures during recruitment and/or informed consent discussions.
• Not suitable for study participation due to other reasons at the discretion of the investigators.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Disclose amyloid, tau results; Release of results from investigational agents conducted under IND 107114, IND 166860, and IND 134516; Other: Follow-up Assessments; self-report psychosocial and behavioral questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Lindsay Clark, PhD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Actual): October 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dementia; communication; risk; Tau; Amyloid; biomarker testing; Alzheimer's Risk; pathophysiological changes
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Frontotemporal Lobar Degeneration; Frontotemporal Dementia; Behavior; Alzheimer Disease; Dementia; Pick Disease of the Brain; Communication
• Other Study ID Numbers: 2025-0685; SMPH/MEDICINE/GER-AD DEV (Other Identifier: UW Madison); Protocol Version 12/10/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: De-identified data can be requested by internal and external researchers through data request procedures set by the source studies.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No