Validation of the MBI-C Scale in French

NCT06516159 | Completed

• 1 other identifier: RC31/22/0323
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 5

Brief Summary

This study aims to validate the French version of the Mild Behavioral Impairment-Checklist (MBI-C) scale, hypothetically effective for measuring behavioral symptoms in patients presenting with a subjective cognitive complaint or mild cognitive impairment (MCI).

Conditions

Subjective Cognitive Complaint; Mild Cognitive Impairment; Neuropsychiatric Symptoms

Outcome Measures

Primary Outcomes (2)

• Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score

  consistency will be assessed using Cronbach's alpha and McDonald's Omega coefficients.

  Baseline

• External validation of the Mild Behavioral Impairment-Checklist score

  Comparison of differences between the scores of the five domains of the NeuroPsychiatric Inventory-Total Questionnaire (NPI-Q) and the MBI-C.

  Baseline

Secondary Outcomes (2)

• Prevalence of Mild Behavioral Impairment (MBI) in memory center patients presenting mild cognitive impairment (MCI) or a subjective cognitive complaint (SCC).

  Baseline

• Determination of the best threshold for the diagnosis of Mild Behavioral Impairment (MBI) in patients with mild cognitive impairment (MCI) or subjective cognitive complaint (SCC).

  Baseline

Study Arms (1)

MBI-C Scale in French

Diagnostic Test: MBI-C Scale in French

Interventions

MBI-C Scale in French DIAGNOSTIC_TEST

The original version has 34 items, divided into 5 areas: * a reduction in motivation, interests and initiative * the appearance of mood disorders * dysregulation of impulse management * loss of conventions and societal norms * the abnormal development of strongly held beliefs and sensory experiences The items are rated based on the occurrence of the severity of the disorders in the previous six months on a scale of 0 to 3. This scale is completed by a member of the healthcare team on the basis of information collected from the relative ("informant") either in person but also by telephone The score varies between 0 and 102. The higher the score, the more psychological and behavioral symptoms are present. The test lasts 10 minutes.

MBI-C Scale in French

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mild cognitive impairment or subjective cognitive complaints will be recruited via memory consultations and memory day hospitals within the Memory Research and Resources Centers (CMRR); centers of excellence for the assessment and diagnosis of cognitive disorders.

You may qualify if:

• Patient presenting a subjective cognitive complaint (SCP) or mild cognitive impairment (MCI) for at least 6 months.
• Patient with a relative visiting them at least once a week.
• No opposition from the patient and his loved one

You may not qualify if:

• Patient presenting criteria for major neurocognitive disorder according to DSM-V criteria.
• Neuropsychiatric symptoms secondary to concomitant treatments, or to a medical or psychiatric pathology.
• Concomitant major depressive episode (DSM-V).
• Presence of concomitant pathologies preventing participation in the study (taking tests).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (5)

University Hospital Limoges

Limoges, 87042, France

Location

University Hospital Nice

Nice, 06100, France

Location

University Hospital Strasbourg

Strasbourg, 67091, France

Location

University Hospital Toulouse

Toulouse, 31059, France

Location

Univsersity Hospital Lyon

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maria SOTO

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 23, 2024
• Study Start: June 26, 2023
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)