Cognitive SymptomMoCATELNCT03232697
French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA)
A study testing Full version of the Montreal Cognitive Assessment and 5 minutes version of the Montreal Cognitive Assessment in people with Cognitive Symptom and Evaluations, Diagnostic Self, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Symptom, Evaluations, Diagnostic Self
- What is being tested?
- Full version of the Montreal Cognitive Assessment and 5 minutes version of the Montreal Cognitive Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2017to 8 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: French Language Validation of the Phone Version of the 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.
Read the 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.
- Conditions
- Cognitive Symptom, Evaluations, Diagnostic Self
- Being tested
- Full version of the Montreal Cognitive Assessment, 5 minutes version of the Montreal Cognitive Assessment
- Medical subject headings
- Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full version of the Montreal Cognitive AssessmentDiagnostic test
Patients or subjects will be submitted to the full version of the MOCA
5 minutes version of the Montreal Cognitive AssessmentDiagnostic test
The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | 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 Receives: Diagnostic Test: Full version of the Montreal Cognitive Assessment; Diagnostic Test: 5 minutes version of the Montreal Cognitive Assessment |
| Alzheimer patients | Other | 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 Receives: Diagnostic Test: Full version of the Montreal Cognitive Assessment; Diagnostic Test: 5 minutes version of the Montreal Cognitive Assessment |
| Parkinson and Huntington patients | Other | 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 Receives: Diagnostic Test: Full version of the Montreal Cognitive Assessment; Diagnostic Test: 5 minutes version of the Montreal Cognitive Assessment |
| Diabetic patients | Other | 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 Receives: Diagnostic Test: Full version of the Montreal Cognitive Assessment; Diagnostic Test: 5 minutes version of the Montreal Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 to 40 days
Secondary outcomes (3)
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
Measured: 30 to 40 days
Test-retest reliability
To determine the test-retest reliability of the short version of the MOCA
Measured: 30 to 40 days
Inter-rater reliability
To determine the inter-rater reliability of the short version of the MOCA
Measured: 30 to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start12 Jul 2017
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive SymptomStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Deplanque, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232697
- Sponsor's protocol ID
- 2016_47
- Other IDs
- 2017-A00131-52
- Acronym
- MoCATEL
- Status last verified
- Aug 2020
- First submitted
- 21 Jul 2017
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Language Validation of the Phone Version of the Montreal Cognitive Assessment (MoCA)
- ClinicalTrials.gov ID
- NCT03232697
- Acronym / sponsor ID
- MoCATEL / 2016_47
- Conditions
- Cognitive Symptom, Evaluations, Diagnostic Self
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Diagnostic Test: Full version of the Montreal Cognitive Assessment, Diagnostic Test: 5 minutes version of the Montreal Cognitive AssessmentSubjects will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment |
| Alzheimer patients | Other | Diagnostic Test: Full version of the Montreal Cognitive Assessment, Diagnostic Test: 5 minutes version of the Montreal Cognitive AssessmentPatients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment |
| Parkinson and Huntington patients | Other | Diagnostic Test: Full version of the Montreal Cognitive Assessment, Diagnostic Test: 5 minutes version of the Montreal Cognitive AssessmentPatients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment |
| Diabetic patients | Other | Diagnostic Test: Full version of the Montreal Cognitive Assessment, Diagnostic Test: 5 minutes version of the Montreal Cognitive AssessmentPatients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full version of the Montreal Cognitive AssessmentPatients or subjects will be submitted to the full version of the MOCA | Diagnostic test | Alzheimer patients, Diabetic patients, Healthy subjects, Parkinson and Huntington patients |
| 5 minutes version of the Montreal Cognitive AssessmentThe same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call | Diagnostic test | Alzheimer patients, Diabetic patients, Healthy subjects, Parkinson and Huntington patients |
Primary outcome
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
3 secondary outcomes
Performance of the short version of the MOCA
Time frame: 30 to 40 days
Test-retest reliability
Time frame: 30 to 40 days
Inter-rater reliability
Time frame: 30 to 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Deplanque, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full version of the Montreal Cognitive Assessment and 5 minutes version of the Montreal Cognitive Assessment in people with Cognitive Symptom and Evaluations, Diagnostic Self, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between scores obtained with the different versions of the MOCA (time frame: 30 to 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.