NCT03232697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

September 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

July 21, 2017

Last Update Submit

September 10, 2020

Conditions

Cognitive SymptomEvaluations, Diagnostic Self

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Performance of the short version of the MOCA

    30 to 40 days

  • Test-retest reliability

    30 to 40 days

  • Inter-rater reliability

    30 to 40 days

Study Arms (4)

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

Diagnostic Test: Full version of the Montreal Cognitive AssessmentDiagnostic 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

Diagnostic Test: Full version of the Montreal Cognitive AssessmentDiagnostic 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

Diagnostic Test: Full version of the Montreal Cognitive AssessmentDiagnostic 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

Diagnostic Test: Full version of the Montreal Cognitive AssessmentDiagnostic Test: 5 minutes version of the Montreal Cognitive Assessment

Interventions

Full version of the Montreal Cognitive AssessmentDIAGNOSTIC_TEST

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

Alzheimer patientsDiabetic patientsHealthy subjectsParkinson and Huntington patients
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

Alzheimer patientsDiabetic patientsHealthy subjectsParkinson and Huntington patients

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Lille, 59037, France

Location

MeSH Terms

Conditions

Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dominique Deplanque, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 28, 2017

Study Start

July 12, 2017

Primary Completion

August 8, 2019

Study Completion

August 8, 2019

Last Updated

September 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)