Clinical trial NCT03232697: French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA)
Official title: French Language Validation of the Phone Version of the Montreal Cognitive Assessment (MoCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Symptom
Evaluations, Diagnostic Self
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 236
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Different populations including subjects with or without cognitive impairment will be used to determine the accuracy of a short version of the MOCA as compared to the full version of this scale.
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to validate a french version of the 5 minutes version of the Montreal Cognitive Assessment as compared to the french full version of this test.

Detailed description: The Montreal Cognitive Assessment (MOCA) is a test used to detect cognitive impairments. This test is available in different languages including french. A short version (the 5 minutes MOCA) has also been validated through a phone call use that allows to develop some epidemiological approaches. Nevertheless, this short version has not been validated in french.

The main aim of the study is to validate the french translation of the short version of the MOCA as compared the the full french version of the test.

To validate the short version, several groups of subjects will be included : healthy subjects, Alzheimer disease patients, Parkinson or Huntington diseases patients as well as diabetic patients.

The inclusion of both healthy subjects and patients with different types of cognitive impairments will allow to validate the short version of the test.

All subjects and patients will first be submitted to the full version of the MOCA during a face to face procedure. Thirty to forty days later, they will be submitted to the short version of the test through a phone call performed by an independent rater.

Subgroups of healthy subjects and patients will also be used to determine the test-retest and inter-rater reliability of the short version of the MOCA.

Eligibility criteria: Inclusion Criteria:

Healthy Volunteers

* Volunteers, BMI \<26
* free from neurological, psychiatric, metabolic or cardiac pathologies;
* Absence of active metabolic or cardiac diseases, unstabilized under treatment
* Pregnant test negative

Patients

* Patients suffering from pathologies that may be accompanied by cognitive decline or dementia (Alzheimer's disease, Parkinson's and Huntington's disease, diabetes) that meet the usual diagnostic criteria for these diseases;
* Patients should not start treatment of a new therapeutic class under test

Exclusion Criteria:

* Pregnant or nursing women.
* Illiterate subjects
* Presence of uncorrected visual or auditory disturbances
* "Alcohol use disorder" observed at the Mini International Neuropsychiatric Inventory (MINI);
* "Substance use disorder" observed at the MINI;
* Participation in a therapeutic trial or in an exclusion period from a previous clinical trial;
* Patient whose physical or mental condition does not allow them to pass the study tests;
* Persons under guardianship or under trusteeship;
* Recent cognitive assessment (less than 6 months) by the classic MoCA

Primary outcomes:
measure: Correlation between scores obtained with the different versions of the MOCA
timeFrame: 30 to 40 days
Secondary outcomes:
measure: Performance of the short version of the MOCA
timeFrame: 30 to 40 days
measure: Test-retest reliability
timeFrame: 30 to 40 days
measure: Inter-rater reliability
timeFrame: 30 to 40 days
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Lille
name: Dominique Deplanque, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: