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

NCT ID: NCT03232697

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-12

Study Completion Date

2019-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Symptom Evaluations, Diagnostic Self

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

Full version of the Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

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

5 minutes version of the Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

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

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

Group Type OTHER

Full version of the Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

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

5 minutes version of the Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

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

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

Group Type OTHER

Full version of the Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

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

5 minutes version of the Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

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

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

Group Type OTHER

Full version of the Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

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

5 minutes version of the Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Full version of the Montreal Cognitive Assessment

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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dominique Deplanque, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Lille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-A00131-52

Identifier Type: OTHER

Identifier Source: secondary_id

2016_47

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.