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Идёт набор NCT06918704

BID WM Digital Intervention in Aging

Без фазы С лечением Working Memory Inhibitory Control Mild Cognitive Impairment (MCI) Aging

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: Coherence, Worder.
Кому может быть актуально
Состояния в реестре: Working Memory, Inhibitory Control, Mild Cognitive Impairment (MCI), Aging. Базовые параметры: 60 лет — 85 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
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Официальное название

Behavioral Intervention Development Core - Working Memory Digital Intervention in Aging

Обзор

The goal of this clinical trial is to learn if engaging with an digital intervention may improve cognitive function. The main questions it aims to answer are: 1. Does engagement in with a digital intervention improve working memory? 2. Does engagement in with a digital intervention improve inhibitory control? Researchers will compare two different digital interventions to assess whether they may be helpful in improving cognitive function. Participants will conduct study activities remotely (e.g., at-home): 1. Baseline Assessment. Complete a series of cognitive assessments and surveys. 2. Intervention. Engage in a digital intervention for up to 8 weeks. 3. Post Intervention Assessment. Complete the same cognitive assessments and surveys as the Baseline Assessment. 4. Follow-Up Assessment. Six months after the intervention ends, participants will complete the same cognitive assessments and surveys as the Baseline Assessment.

Подробное описание

During the Baseline Assessment, participants will complete web-based cognitive assessments and surveys. The assessments will address various cognitive functions including working memory, long-term memory, inhibitory control, and sustained attention. Surveys will include a characterization of expectancy for the intervention, ratings of stress, and background health information. The Baseline Assessment will take up to 120 minutes and can be completed across more than one session.

During the Intervention, participants will be provided an iPad tablet to engage with the assigned intervention app. Participants will be randomly assigned to one of two intervention apps. Regardless of the assigned intervention, participants will engage with the app for 25-45 minutes of training per day, 5 days a week for up to 8 weeks for a total of 1000 minutes of training.

After the intervention, participants will complete a Post Intervention Assessment and 6 month later, a Follow-Up Assessment. Both of these assessment periods will consist of the same cognitive assessments and surveys as conducted during the Baseline Assessment.

Upon completion of all study activities, participants will be able to keep the iPad as a gift for their voluntary participation.

Вмешательства

  • Поведенческое Coherence
    Coherence is a music-based rhythm training app.
  • Поведенческое Worder
    Worder is a word search app.

Первичные конечные точки

  • Working Memory [Срок оценки: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention]
Вторичные конечные точки (2)
  • Inhibitory Control [Срок оценки: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention]
  • Inhibitory Control [Срок оценки: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention]

Критерии участия

Критерии включения

  • Minimum of 12 years of education
  • English fluency
  • Normal or corrected-to-normal vision
  • Normal or corrected-to-normal vision
  • Medically healthy older adults including those with below-average cognitive performance or mild cognitive impairment patients without dementia

Критерии исключения

  • Under the age of 60
  • Clinical diagnosis of neurological or psychiatric disorder
  • Visually or hearing impaired without correction to normal
  • Clinical diagnosis of dementia or AD8 score of >3
  • Regularly (one or more times per week) practicing an instrument within the last year
  • 10 or more years of formal musical instrument training

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06918704 · 24-42925 · P30AG086635

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗