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Alzheimer DiseaseNCT07222930

Learning Amyloid and Tau Results

An observational study of Alzheimer Disease, run by University of Wisconsin, Madison at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
Disclose amyloid, tau results and Follow-up Assessments
How many people
240 participants
Where
1 siteUnited States
Study dates
17 Feb 2026to Jun 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53792

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Disclose amyloid, tau results, Follow-up Assessments
Keywords
Amyloid, Tau, Alzheimer's Risk, dementia, biomarker testing, risk, pathophysiological changes, communication
Medical subject headings
Alzheimer Disease, Pick Disease of the Brain, Dementia, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Disclose amyloid, tau resultsOther

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

  • Follow-up AssessmentsOther

    self-report psychosocial and behavioral questionnaires

Study groups in NCT07222930
Study groupRoleWhat they receive
Participants from UW Alzheimer's Disease ResearchParticipants 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.
Receives: Other: Disclose amyloid, tau results; Other: Follow-up Assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month, 6 months, 12 months, 18 months

  2. 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.

    Measured: 1 month, 6 months, 12 months, 18 months

  3. 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.

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

  4. Future Time Perspective Scale

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

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

Secondary outcomes (9)

  1. Willingness to Prevent AD

    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.

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

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

    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.

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

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

    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. .

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

  4. Cognitive & Leisure Activity Scale (CLAS)

    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.

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

  5. 6-item questionnaire for Mediterranean diet

    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.

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

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

    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.

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

  7. Number of Participants who Complete Advanced Directives

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

  8. Clinical Trial Enrollment

    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".

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

  9. Communication Assessment Tool (CAT) Score

    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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2025
  2. Study start17 Feb 2026
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07222930
Sponsor's protocol ID
2025-0685
Other IDs
Protocol Version 5/11/26, SMPH/MEDICINE/GER-AD DEV
Status last verified
May 2026
First submitted
29 Oct 2025
Last updated
24 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be stored and shared back with the larger source studies (Wisconsin Registry for Alzheimer's Prevention and Wisconsin Alzheimer's Disease Research Center) to allow for investigators to request the data for future analyses.

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Score (time frame: 1 month, 6 months, 12 months, 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07222930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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