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Набор скоро начнётся NCT07251647

Adaptation of the Mini-Mental State Examination (MMSE) for the Reunion Island Population

Без фазы С лечением Alzheimer s Disease Vascular Cognitive 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: MMSE-RUN and MMSE GRECO.
Кому может быть актуально
Состояния в реестре: Alzheimer s Disease, Vascular Cognitive 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
Reunion
Следующий шаг
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Обзор

The Mini-Mental State Examination (MMSE) is the most widely used cognitive screening and monitoring test for neurocognitive disorders in current clinical practice. Its French version was published in 1998 by the GRECO group (MMSE-GRECO). However, some items of this French version are not adapted to local Reunionese particularities. The main objective is to propose and validate the psychometric properties of an adapted version of the MMSE, to the Reunionese culture (MMSE-RUN) in a healthy population and in a sick population (Alzheimer's Disease and Vascular Cognitive Disorder), and to compare its performance with the MMSE-GRECO.

Подробное описание

The MMSE score was described in 1975 by an American psychiatrist. Due to its good psychometric properties and its quick and simple administration, it has become the most widely known and used screening and monitoring test for neurocognitive disorders. The MMSE have been translated and adapted for use in many languages and cultures worldwide. Its brevity, ease of use, and established psychometric properties have contributed to its widespread adoption in clinical practice and research settings for detecting cognitive impairment and monitoring cognitive changes over time.

It has been adapted into French (MMSE-GRECO), as well as to other cultures in Europe, Asia, and Africa. In the French overseas territories, a Polynesian and Caribbean version have been published.

In Reunion Island, no adapted version has been published yet. Nevertheless, an early identification of cognitive disorders with adapted screening tools is essential because three risk factors for cognitive vulnerability converge: (1) an aging population (increasing the risk of developing Alzheimer's disease) with (2) a lower level of education (decreasing cognitive resilience), and (3) a higher frequency of cardiovascular risk factors (hypertension, diabetes, dyslipidemia), increasing the frequency of vascular cognitive disorders.

The objective of this study is to propose an adapted version of the test for the Reunion Island population (MMSE-RUN) and to validate its psychometric properties within a cohort of healthy subjects and patients (Alzheimer's disease and/or vascular cognitive disorder).

Вмешательства

  • Диагностический тест MMSE-RUN and MMSE GRECO
    Each participant (control and Case) will complete MMSE-RUN and MMSE-GRECO.

Первичные конечные точки

  • Internal consistency - Cronbach's alpha [Срок оценки: Day 1]
  • Construct validity - Exploratory Factor Analysis [Срок оценки: Day 1]
  • Criterion validity - t test [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • For the healthy population : aged 60 to 89 years, residing in Reunion for more than 5 years, able to understand the test instructions, available for a one-hour interview, affiliated with a social security scheme, with informed consent.
  • For the sick population : aged 60 to 89 years, residing in Reunion for more than 5 years, presenting probable or possible Alzheimer's disease and/or probable vascular cognitive disorder, able to understand the test instructions, available for a one-hour interview, affiliated with a social security scheme, with informed consent.

Критерии исключения

  • For the healthy populationhistory of neurological pathology, neurodegenerative pathology with cognitive expression, refusing to participate in the study, under legal protection.
  • For the sick population: acute unresolved medical decompensation or acute psychic decompensation, refusing to participate in the study, under legal protection.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Reunion · 7 центров
  • CHU de La Réunion - site Nord - Geriatric department — Saint-Denis
  • CHU de La Réunion - site Nord - Neurology department — Saint-Denis
  • Centre Hospitalier Ouest Réunion (CHOR) — Saint-Paul
  • CHU de La Réunion - site Sud - Geriatric department — Saint-Pierre
  • CHU de La Réunion - site Sud - Neurology department — Saint-Pierre
  • CHU de La Réunion — Saint-Pierre
  • Functional Rehabilitation Center — Sainte-Clotilde

Идентификаторы

NCT: NCT07251647 · 2025/CHU/10

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗