Меню
Идёт набор NCT06792877

Mindfulness for Cognition in Early-stage Alzheimer's Disease

Без фазы С лечением Mild Cognitive Impairment (MCI) Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease TBI (Traumatic Brain Injury) 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: Mindfulness Intervention, Waitlist then mindfulness.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, TBI (Traumatic Brain Injury), Aging. Базовые параметры: 50 лет — 100 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Mechanisms of Mindfulness for Cognition in Early-Stage Alzheimer's Disease

Обзор

The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are: 1. How does mindfulness impact thinking and memory? 2. How does mindfulness influence brain function and structure? 3. How does mindfulness affect daily function and quality of life? Researchers will compare all outcomes to one other groups. In one group, individuals will participate in a mindfulness class intervention; in the other group, individuals will not engage in any active interventions immediately, but will be placed on a waitlist for the mindfulness intervention. Researchers will compare all outcomes between the groups groups to determine whether the mindfulness interventions leads to greater improvement compared to no intervention (waitlist group). Participants will: * Be randomly assigned to participate in the mindfulness intervention, or no immediate intervention (waitlist) * Complete paper-and-pencil cognitive testing, surveys, computerized tasks, and neuroimaging measures (EEG and MRI) before and after the intervention Outcomes will be assess at baseline, 2 months, 4 months and 6 months.

Вмешательства

  • Поведенческое Mindfulness Intervention
    The Mindfulness Intervention is an adapted form of Mindfulness-based stress reduction (MBSR) training virtual class that meets for 10 weeks. The class involves mindfulness training using awareness and focused attention, group discussion of the experience, and mindful movement. The Mindfulness Intervention also includes daily home practice using mindfulness recordings.
  • Поведенческое Waitlist then mindfulness
    Participants in this arm will first wait 10 weeks and then complete a mindfulness course with outcome measures assessed at baseline, after 10 weeks wait list and then after mindfulness course.

Первичные конечные точки

  • Neuropsychological tests [Срок оценки: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)]
  • Performance on computerized tasks [Срок оценки: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)]
  • Resting state and event-related electrophysiology [Срок оценки: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)]
  • Brain function and structure [Срок оценки: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))]
  • Survey outcomes [Срок оценки: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))]

Критерии участия

Критерии включения

  • Healthy older adults will show cognitive performance within 1.0 SD for age \& education adjusted norms on a neuropsychological test battery
  • Mild cognitive impairment (MCI) participants will show performance on delayed recall or one more or more other cognitive domains worse than 1.5 SD for age \& education adjusted norms, an MMSE score between 25-30, and a MoCA score between 20-30.

Критерии исключения

  • Participants without a computer, smart phone and internet access will be excluded
  • If they cannot understand the informed consent form or have moderate dementia.
  • Mood disorders (e.g., PTSD, depression, anxiety) or alcohol and drug use that either interferes with day-to-day life or required hospitalization within the past 5 years
  • Cerebrovascular disease
  • Any medical condition whose severity could significantly impair cognition (e.g., stroke, frontotermporal dementia, Parkinson's disease) are exclusionary

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
  • VA Boston Healthcare System - Jamaica Plain Campus — Boston

Идентификаторы

NCT: NCT06792877 · 1796795

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗