NCT03324711

Brief Summary

The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa). The methodology used will permit to explore the feasibility, acceptability, validity and reliability of the tool. The psychometric validation of a version adapted transculturally will increase the value of the results obtained with this test and will make it possible to refine the screening of existing cognitive disorders for elderly subjects with Alzheiner's disease or related disorders.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

January 11, 2017

Last Update Submit

February 22, 2022

Conditions

Keywords

Cognitive disordersAlzheimer's diseaseMini Mental State ExaminationGeriatry

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the psychometric properties of the questionnaire MMSEa

    The following will be measured: * feasibility and acceptability; * validity of structure; * discriminant validity; * predictive validity; * validity of convergence; * reliability (internal consistency,reproducibility (test-retest)).

    12 month (+/- 15 days)

Secondary Outcomes (1)

  • Evaluation of the psychometric properties of questionnaire SPPB

    12 month (+/- 15 days)

Study Arms (1)

Elderly patient (65 and more)

OTHER

Ederly patients seen in geriatric day hospital, from creole culture.

Diagnostic Test: "Antillanisée" Mini Mental State Examination (MMSEa)

Interventions

"Antillanisée" version of the Mini Mental State Examination (MMSEa), is a version adaptated to the French West Indies creole culture.

Also known as: MMSEa
Elderly patient (65 and more)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subject of 65 years old and over
  • Subject admitted in a geriatric day hospital
  • Patients of creole culture
  • Subject having French and/or Creole as mother tongue
  • Subject able to undergo neuropsychological tests
  • Subject having given informed consent or, informed consent given by his or her primary caregiver
  • Subject affiliated to a social security scheme

You may not qualify if:

  • Subject with a disability seriously compromising oral communication (understanding and expression)
  • Subject with behavioral disorder that does not allow for testing
  • Subject in general condition not allowing its participation in the tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Martinique

Fort-de-France, Martinique, 97200, France

Location

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Lidvine GODAERT-SIMON, MD

    CHU of Martinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

October 30, 2017

Study Start

November 15, 2016

Primary Completion

April 11, 2019

Study Completion

July 1, 2019

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations