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

Primary Purpose

Cognitive Symptom, Evaluations, Diagnostic Self

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Full version of the Montreal Cognitive Assessment
5 minutes version of the Montreal Cognitive Assessment
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cognitive Symptom

Eligibility Criteria

40 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Healthy subjects

Alzheimer patients

Parkinson and Huntington patients

Diabetic patients

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Test-retest reliability
To determine the test-retest reliability of the short version of the MOCA
Inter-rater reliability
To determine the inter-rater reliability of the short version of the MOCA

Full Information

First Posted
July 21, 2017
Last Updated
September 10, 2020
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03232697
Brief Title
French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA)
Acronym
MoCATEL
Official Title
French Language Validation of the Phone Version of the Montreal Cognitive Assessment (MoCA)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Symptom, Evaluations, Diagnostic Self

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Other
Arm Description
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
Arm Title
Alzheimer patients
Arm Type
Other
Arm Description
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
Arm Title
Parkinson and Huntington patients
Arm Type
Other
Arm Description
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
Arm Title
Diabetic patients
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Full version of the Montreal Cognitive Assessment
Intervention Description
Patients or subjects will be submitted to the full version of the MOCA
Intervention Type
Diagnostic Test
Intervention Name(s)
5 minutes version of the Montreal Cognitive Assessment
Intervention Description
The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call
Primary Outcome Measure Information:
Title
Correlation between scores obtained with the different versions of the MOCA
Description
To measure the correlation between the results obtained at the short and full versions of the MOCA
Time Frame
30 to 40 days
Secondary Outcome Measure Information:
Title
Performance of the short version of the MOCA
Description
Receiver operator characteristic (ROC) analyses of the short version of MOCA to determine cognitive impairment as compared to full version as a gold-standard
Time Frame
30 to 40 days
Title
Test-retest reliability
Description
To determine the test-retest reliability of the short version of the MOCA
Time Frame
30 to 40 days
Title
Inter-rater reliability
Description
To determine the inter-rater reliability of the short version of the MOCA
Time Frame
30 to 40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Deplanque, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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