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Набор по приглашению NCT07222930

Learning Amyloid and Tau Results

— Наблюдательное Alzheimer Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Disclose amyloid, tau results, Follow-up Assessments.
Кому может быть актуально
Состояния в реестре: Alzheimer Disease. Базовые параметры: 45 лет — 89 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Disclose amyloid, tau results
    Release of results from investigational agents conducted under IND 107114, IND 166860, and IND 134516
  • Другое Follow-up Assessments
    self-report psychosocial and behavioral questionnaires

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Wisconsin — Madison

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗