French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA) (MoCATEL)

French Language Validation of the Phone Version of the Montreal Cognitive Assessment (MoCA)

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Symptom; Evaluations, Diagnostic Self
• Intervention / Treatment: Diagnostic test: Full version of the Montreal Cognitive Assessment; Diagnostic test: 5 minutes version of the Montreal Cognitive Assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy subjects; Subjects will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment	Diagnostic test: Full version of the Montreal Cognitive Assessment; Patients or subjects will be submitted to the full version of the MOCA; Diagnostic test: 5 minutes version of the Montreal Cognitive Assessment; The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call
Other: Alzheimer patients; Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment	Diagnostic test: Full version of the Montreal Cognitive Assessment; Patients or subjects will be submitted to the full version of the MOCA; Diagnostic test: 5 minutes version of the Montreal Cognitive Assessment; The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call
Other: Parkinson and Huntington patients; Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment	Diagnostic test: Full version of the Montreal Cognitive Assessment; Patients or subjects will be submitted to the full version of the MOCA; Diagnostic test: 5 minutes version of the Montreal Cognitive Assessment; The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call
Other: Diabetic patients; Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment	Diagnostic test: Full version of the Montreal Cognitive Assessment; Patients or subjects will be submitted to the full version of the MOCA; Diagnostic test: 5 minutes version of the Montreal Cognitive Assessment; The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between scores obtained with the different versions of the MOCA	To measure the correlation between the results obtained at the short and full versions of the MOCA	30 to 40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the short version of the MOCA	Receiver operator characteristic (ROC) analyses of the short version of MOCA to determine cognitive impairment as compared to full version as a gold-standard	30 to 40 days
Test-retest reliability	To determine the test-retest reliability of the short version of the MOCA	30 to 40 days
Inter-rater reliability	To determine the inter-rater reliability of the short version of the MOCA	30 to 40 days

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Dominique Deplanque, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): August 8, 2019
• Study Completion (Actual): August 8, 2019

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations
• Other Study ID Numbers: 2016_47; 2017-A00131-52 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No