University of Wisconsin
Madison, Wisconsin, 53792, United States
NCT Number: NCT07222930
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.
Interested in participating?
Request Info45 year–89 year
All sexes
Observational
Madison, Wisconsin, 53792, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Release of results from investigational agents conducted under IND 107114, IND 166860, and IND 134516
self-report psychosocial and behavioral questionnaires
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.
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.
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.
Time frame: baseline, 1 month, 6 months, 12 months, 18 months
Scores are from 1-7 where higher scores indicate higher engagement.
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.
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.
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. .
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.
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.
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.
Time frame: baseline, 1 month, 6 months, 12 months, 18 months
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".
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.
University of Wisconsin, Madison
Other
Reactions to Learning Amyloid and Tau Results in Adults at Risk for Alzheimer's Dementia
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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