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Enrolling by invitation NCT07222930

Learning Amyloid and Tau Results

— Observational Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Disclose amyloid, tau results, Follow-up Assessments.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: 45 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • 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

Primary outcome measures

  • Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Score [Time frame: 1 month, 6 months, 12 months, 18 months]
  • Stigma Impact Scale (SIS) Score [Time frame: 1 month, 6 months, 12 months, 18 months]
  • Control, Autonomy, Self-Realization, and Pleasure (CASP-12) [Time frame: baseline, 1 month, 6 months, 12 months, 18 months]
  • Future Time Perspective Scale [Time frame: baseline, 1 month, 6 months, 12 months, 18 months]
Secondary outcome measures (9)
  • Willingness to Prevent AD [Time frame: baseline, 1 month, 6 months, 12 months, 18 months]
  • Willingness to Prevent AD: Over the counter, prescription, clinical trial items [Time frame: baseline, 1 month, 6 months, 12 months, 18 months]
  • Exercise Vital Sign Tool: Minutes per Week of Moderate or Vigorous Exercise [Time frame: baseline, 1 month, 6 months, 12 months, 18 months]
  • Cognitive & Leisure Activity Scale (CLAS) [Time frame: baseline, 1 month, 6 months, 12 months, 18 months]
  • 6-item questionnaire for Mediterranean diet [Time frame: baseline, 1 month, 6 months, 12 months, 18 months]
  • Brief Pittsburgh Sleep Quality Index (B-PSQI) [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 [Time frame: baseline, 1 month, 6 months, 12 months, 18 months]
  • Communication Assessment Tool (CAT) Score [Time frame: 1 month]

Eligibility criteria

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 45 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Wisconsin — Madison

Identifiers

NCT: NCT07222930 · 2025-0685 · Protocol Version 5/11/26 · SMPH/MEDICINE/GER-AD DEV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗