Alzheimer s DiseaseMMSE-RUNNCT07251647
Adaptation of the Mini-Mental State Examination (MMSE) for the Reunion Island Population
A study testing MMSE-RUN and MMSE GRECO in people with Alzheimer s Disease and Vascular Cognitive Impairment, run by Centre Hospitalier Universitaire de la Réunion at 7 sites in Reunion.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer s Disease, Vascular Cognitive Impairment
- What is being tested?
- MMSE-RUN and MMSE GRECO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 7 sitesReunion
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Reunion7 sites
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
About this study
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.
Read the detailed description
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).
- Conditions
- Alzheimer s Disease, Vascular Cognitive Impairment
- Being tested
- MMSE-RUN and MMSE GRECO
- Keywords
- Neurocognitive disorder, cognitive test, screening, Reunion Island
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSE-RUN and MMSE GRECODiagnostic test
Each participant (control and Case) will complete MMSE-RUN and MMSE-GRECO.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (Healthy indivuduals) | Other | MMSE-RUN and MMSE GRECO questionnaires Receives: 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 Receives: Diagnostic Test: MMSE-RUN and MMSE GRECO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251647
- Sponsor's protocol ID
- 2025/CHU/10
- Acronym
- MMSE-RUN
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Mini-Mental State Examination (MMSE) for the Reunion Island Population
- ClinicalTrials.gov ID
- NCT07251647
- Acronym / sponsor ID
- MMSE-RUN / 2025/CHU/10
- Conditions
- Alzheimer s Disease, Vascular Cognitive Impairment
- Keywords
- Neurocognitive disorder, cognitive test, screening, Reunion Island
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm (Healthy indivuduals) | Other | Diagnostic Test: MMSE-RUN and MMSE GRECOMMSE-RUN and MMSE GRECO questionnaires |
| Case Arm (Patients with Alzheimer's disease or vascular cognitive impairment) | Other | Diagnostic Test: MMSE-RUN and MMSE GRECOMMSE-RUN and MMSE GRECO questionnaires |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMSE-RUN and MMSE GRECOEach participant (control and Case) will complete MMSE-RUN and MMSE-GRECO. | Diagnostic test | Case Arm (Patients with Alzheimer's disease or vascular cognitive impairment), Control Arm (Healthy indivuduals) |
Primary outcome
Internal consistency - Cronbach's alpha
Time frame: Day 1
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.
Construct validity - Exploratory Factor Analysis
Time frame: Day 1
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.
Criterion validity - t test
Time frame: Day 1
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMSE-RUN and MMSE GRECO in people with Alzheimer s Disease and Vascular Cognitive Impairment, run by Centre Hospitalier Universitaire de la Réunion at 7 sites in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency - Cronbach's alpha (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.