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

Cognitive Symptom Clinical Trial

— MoCATEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232697
• Other study ID #: 2016_47
• Secondary ID: 2017-A00131-52
• Status: Completed
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: August 8, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Symptom
• Evaluations, Diagnostic Self
• Neurobehavioral Manifestations

Intervention

Diagnostic Test:
• Full version of the Montreal Cognitive Assessment
Patients or subjects will be submitted to the full version of the MOCA
• 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

Locations

Country	Name	City	State
France	University Hospital	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Test-retest reliability	To determine the test-retest reliability of the short version of the MOCA	30 to 40 days
Secondary	Inter-rater reliability	To determine the inter-rater reliability of the short version of the MOCA	30 to 40 days