Learning Amyloid and Tau Results

NCT07222930 | Not Yet Recruiting FDA Drug

• 3 other identifiers: 2025-0685Protocol Version 12/10/25SMPH/MEDICINE/GER-AD DEV
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Amyloid; Tau; Alzheimer's Risk; dementia; biomarker testing; risk; pathophysiological changes; communication

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Willingness to Prevent AD

  baseline, 1 month, 6 months, 12 months, 18 months

• Willingness to Prevent AD: Over the counter, prescription, clinical trial items

  baseline, 1 month, 6 months, 12 months, 18 months

• Exercise Vital Sign Tool: Minutes per Week of Moderate or Vigorous Exercise

  baseline, 1 month, 6 months, 12 months, 18 months

• Cognitive & Leisure Activity Scale (CLAS)

  baseline, 1 month, 6 months, 12 months, 18 months

• 6-item questionnaire for Mediterranean diet

  baseline, 1 month, 6 months, 12 months, 18 months

Study Arms (1)

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; Other: Follow-up Assessments

Interventions

Disclose amyloid, tau results OTHER

Release of results from investigational agents conducted under IND 107114, IND 166860, and IND 134516

Participants from UW Alzheimer's Disease Research

Follow-up Assessments OTHER

self-report psychosocial and behavioral questionnaires

Participants from UW Alzheimer's Disease Research

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Pick Disease of the Brain; Dementia; Communication

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Behavior

Study Officials

• Lindsay Clark, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Clark, PhD

CONTACT

608-890-4150; lrclark@medicine.wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 30, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)