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

Sponsor
University Hospital, Lille (Other)
Overall Status
Completed
CT.gov ID
NCT03232697
Collaborator
(none)
236
1
4
24.9
9.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Full version of the Montreal Cognitive Assessment
  • Diagnostic Test: 5 minutes version of the Montreal Cognitive Assessment
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
236 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
French Language Validation of the Phone Version of the Montreal Cognitive Assessment (MoCA)
Actual Study Start Date :
Jul 12, 2017
Actual Primary Completion Date :
Aug 8, 2019
Actual Study Completion Date :
Aug 8, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Correlation between scores obtained with the different versions of the MOCA [30 to 40 days]

    To measure the correlation between the results obtained at the short and full versions of the MOCA

Secondary Outcome Measures

  1. Performance of the short version of the MOCA [30 to 40 days]

    Receiver operator characteristic (ROC) analyses of the short version of MOCA to determine cognitive impairment as compared to full version as a gold-standard

  2. Test-retest reliability [30 to 40 days]

    To determine the test-retest reliability of the short version of the MOCA

  3. Inter-rater reliability [30 to 40 days]

    To determine the inter-rater reliability of the short version of the MOCA

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Lille France 59037

Sponsors and Collaborators

  • University Hospital, Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT03232697
Other Study ID Numbers:
  • 2016_47
  • 2017-A00131-52
First Posted:
Jul 28, 2017
Last Update Posted:
Sep 11, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2020