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Enrolling by Invitation

NCT Number: NCT07222930

Learning Amyloid and Tau Results

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.

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Key information

Age range

45 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Disclose amyloid, tau results

Other

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

Follow-up Assessments

Other

self-report psychosocial and behavioral questionnaires

Primary outcomes

  1. Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Score

    Time frame: 1 month, 6 months, 12 months, 18 months

    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.

  2. Stigma Impact Scale (SIS) Score

    Time frame: 1 month, 6 months, 12 months, 18 months

    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.

  3. Control, Autonomy, Self-Realization, and Pleasure (CASP-12)

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    This is a quality of life measure scored from 0-36 where higher scores mean better quality of life.

  4. Future Time Perspective Scale

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    Scores are from 1-7 where higher scores indicate higher engagement.

Secondary outcomes

  1. Willingness to Prevent AD

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    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.

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

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    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.

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

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    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. .

  4. Cognitive & Leisure Activity Scale (CLAS)

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    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.

  5. 6-item questionnaire for Mediterranean diet

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    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.

  6. Brief Pittsburgh Sleep Quality Index (B-PSQI)

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    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.

  7. Number of Participants who Complete Advanced Directives

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

  8. Clinical Trial Enrollment

    Time frame: baseline, 1 month, 6 months, 12 months, 18 months

    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".

  9. Communication Assessment Tool (CAT) Score

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Oct 30, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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