NCT07251647

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Apr 2026

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Jul 2027

First Submitted

Initial submission to the registry

October 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

October 2, 2025

Last Update Submit

March 11, 2026

Conditions

Keywords

Neurocognitive disordercognitive testscreeningReunion Island

Outcome Measures

Primary Outcomes (3)

  • Internal consistency - Cronbach's alpha

    Internal consistency measures the extent to which the items in the test measure the same dimension or concept, in this case overall cognitive efficiency. Internal consistency is commonly measured by Cronbach's alpha, which ranges from 0 (low) to 1 (high). A high coefficient indicates that the test items are similar in content, i.e. homogeneous. A Cronbach's alpha greater than 0.7 is acceptable.

    Day 1

  • Construct validity - Exploratory Factor Analysis

    Construct validity allows us to visualise the construction of the test and the concept measured by the instrument in healthy population. The existence of seven independent factors must be demonstrated by Exploratory Factor Analysis: temporal orientation, spatial orientation, learning three words, mental arithmetic, recall, language and constructive praxis.

    Day 1

  • Criterion validity - t test

    Criterion validity consists of verifying an instrument's ability to distinguish between individuals; ie, it is the test's ability to clearly identify a deficit in overall cognitive efficiency in a population affected by a pathology, compared to a cognitively healthy population. The validity of this criterion will be assessed using a Student's t-test comparing the MMSE-RUN scores obtained by the healthy subjects group and the pathological subjects group.

    Day 1

Study Arms (2)

Control Arm (Healthy indivuduals)

OTHER

MMSE-RUN and MMSE GRECO questionnaires

Diagnostic Test: MMSE-RUN and MMSE GRECO

Case Arm (Patients with Alzheimer's disease or vascular cognitive impairment)

OTHER

MMSE-RUN and MMSE GRECO questionnaires

Diagnostic Test: MMSE-RUN and MMSE GRECO

Interventions

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

Case Arm (Patients with Alzheimer's disease or vascular cognitive impairment)Control Arm (Healthy indivuduals)

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU de La Réunion - site Nord - Geriatric department

Saint-Denis, Reunion

Location

CHU de La Réunion - site Nord - Neurology department

Saint-Denis, Reunion

Location

Centre Hospitalier Ouest Réunion (CHOR)

Saint-Paul, Reunion

Location

CHU de La Réunion - site Sud - Geriatric department

Saint-Pierre, Reunion

Location

CHU de La Réunion - site Sud - Neurology department

Saint-Pierre, Reunion

Location

CHU de La Réunion

Saint-Pierre, Reunion

Location

Functional Rehabilitation Center

Sainte-Clotilde, Reunion

Location

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2025

First Posted

November 26, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations