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Completed

NCT Number: NCT03232697

French Language Validation of the 5-minutes 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.

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Key information

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full version of the Montreal Cognitive Assessment

Diagnostic Test

Patients or subjects will be submitted to the full version of the MOCA

5 minutes version of the Montreal Cognitive Assessment

Diagnostic Test

The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call

Primary outcomes

  1. Correlation between scores obtained with the different versions of the MOCA

    Time frame: 30 to 40 days

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

Secondary outcomes

  1. Performance of the short version of the MOCA

    Time frame: 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

    Time frame: 30 to 40 days

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

  3. Inter-rater reliability

    Time frame: 30 to 40 days

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: MoCATEL

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2017
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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