Learning Amyloid and Tau Results

University of Wisconsin (UW)

Status: Not yet enrolling

Conditions: Alzheimer Disease

Treatments: Other: Disclose amyloid, tau results; Other: Follow-up Assessments

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07222930

SMPH/MEDICINE/GER-AD DEV (Other Identifier)

2025-0685

Protocol Version 12/10/25 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 50 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

240 participants in 1 patient group

Participants from UW Alzheimer's Disease Research

Description:

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.

Treatment:

Other: Follow-up Assessments

Other: Disclose amyloid, tau results