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Идёт набор NCT07130669

FACE Phase II (a Stage II Trial)

Фаза I / Фаза II С лечением MCI Subjective Cognitive Decline (SCD) Mild Behavioral Impairment

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: Cognitive Remediation, Cognitive Remediation II.
Кому может быть актуально
Состояния в реестре: MCI, Subjective Cognitive Decline (SCD), Mild Behavioral Impairment. Базовые параметры: 60 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

A Facial Expression-based Personalization Engine (FPE) for Monitoring and Modulating Real-time Effective Engagement in Cognitive Training in Older Adults at Risk for AD/ADRD (CogT FACE Study Phase II)

Обзор

How to ensure adherence to computerized cognitive training in unsupervised circumstances (e.g., at-home, self-administered) in older adults at risk for Alzheimer's disease (AD) or AD related dementia (AD/ADRD) is understudied. The objective of the R33 study is to test a novel facial expression-based personalization engine (FPE) for monitoring and modulating real-time effective engagement, with an ultimate goal of enhancing long-term adherence in unsupervised cognitive training in older adults at risk for AD/ADRD. Here, Effective engagement is defined as the extent to which someone is actively engaged and performing with significant attention and enjoyment while training, addressing a balance between adherence and cognitive gains/plasticity from the training. Based on previous work, the hypotheses include that (1) mental fatigue revealed in facial expressions will reflect a trainee's degree of effective engagement, which can be modified by modulating task novelty; (2) the proposed FPE will ensure the effective engagement in cognitive training by monitoring trainee facial expressions and modulating training in response, promoting the trainee's long-term adherence to the training and cognitive plasticity. A Stage II intervention efficacy study will be conducted to compare effective engagement and adherence in unsupervised cognitive training between training programs with vs. without FPE in older adults at risk for AD/ADRD. The proposed FPE may assist in monitoring and improving effective engagement and adherence in older adults with unsupervised cognitive training. In the current application, FPE in a cognitive training program called speed of processing training will be tested. However, such FPE may be embedded to any computerized cognitive training in future studies to help address adherence related issues.

Вмешательства

  • Поведенческое Cognitive Remediation
    computerized cognitive training with a closed-loop human machine interface that monitor facial expression as engagement status of the person
  • Поведенческое Cognitive Remediation II
    traditional computerized cognitive training

Первичные конечные точки

  • multi-modal effective engagement index (AID) [Срок оценки: up to 8 weeks, throughout the intervention sessions]
Вторичные конечные точки (4)
  • the time spent on training [Срок оценки: up to 8 weeks, throughout the intervention sessions]
  • self-report perceived fatigue [Срок оценки: up to 8 weeks, throughout the intervention sessions]
  • memory [Срок оценки: baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13]
  • executive function [Срок оценки: baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13]

Критерии участия

Критерии включения

  • English speaking
  • Aged 60-89
  • Living in a home, or independent- or assisted-living facility
  • Adequate visual and hearing acuity
  • Anti-depressants, antipsychotics, and/or anxiolytics have been stable for at least 7 days
  • Memory medications have been stable for at least 3 months
  • Absence of neurological/vascular disorder (For neurological disorders with minor symptoms check with PI on case-by-case basis)

Критерии исключения

  • be enrolled in another intervention study aimed at improving cognition
  • live in nursing home
  • diagnosed with Multiple Sclerosis, TBI, chronic heart failure, Parkinson's disease, dementia

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
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Stanford University CogT Lab — Palo Alto

Идентификаторы

NCT: NCT07130669 · 82182

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗