Learning Amyloid and Tau Results

NCT ID: NCT07222930

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-28

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Disclose amyloid, tau results

Intervention Type OTHER

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

Follow-up Assessments

Intervention Type OTHER

self-report psychosocial and behavioral questionnaires

Interventions

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Disclose amyloid, tau results

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

Intervention Type OTHER

Follow-up Assessments

self-report psychosocial and behavioral questionnaires

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lindsay Clark, PhD

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Central Contacts

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Lindsay Clark, PhD

Role: CONTACT

608-890-4150

Other Identifiers

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Protocol Version 12/10/25

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/GER-AD DEV

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0685

Identifier Type: -

Identifier Source: org_study_id

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