Validation of the MBI-C Scale in French

Completed

• Conditions: Mild Cognitive Impairment; Subjective Cognitive Complaint; Neuropsychiatric Symptoms
• Interventions: Diagnostic Test: MBI-C Scale in French

• Registration Number: NCT06516159
• Lead Sponsor: University Hospital, Toulouse

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).

Detailed Description

Neuropsychiatric symptoms are common in the prodromal stage of dementia and may precede cognitive impairment. Their presence in patients without cognitive impairment, but with a subjective cognitive complaint or mild cognitive impairment (MCI), is associated with an increased risk of progression to dementia. The concept of Mild Behavioral Impairment (MBI) was developed to identify populations at risk from the early stages of the disease. MBI is characterized by long-lasting psychiatric symptoms appearing late, in patients without cognitive deficits or with MCI, and can precede dementia.

The general hypothesis is that the French version of the Mild Behavioral Impairment-Checklist (MBI-C) scale has good psychometric capabilities to correctly measure behavioral symptoms in patients with subjective cognitive complaint or MCI. The main objective is to verify the reliability and internal and external validity of the MBI-C score. Secondary objectives include studying the prevalence of MBI and determining the best cutoff for the diagnosis of MBI in patients with MBI or subjective cognitive complaint.

This is an observational, national, multicenter and cross-sectional study. It will include 170 patients (5 per scale item, or 34 items), with an inclusion period of 24 months and a total research duration of 25 months. Patients must be over 50 years old, have had subjective cognitive complaint or mild cognitive impairment for at least 6 months, and have a person who visits them at least once a week.

Validation of the MBI-C scale in French could play a crucial role in the identification and early management of neurodegenerative disorders.

Study Timeline

• Study Start: 2023-06-26
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MBI-C Scale in French	MBI-C Scale in French	-

Primary Outcome Measures

Name	Time	Method
External validation of the Mild Behavioral Impairment-Checklist score	Baseline	Comparison of differences between the scores of the five domains of the NeuroPsychiatric Inventory-Total Questionnaire (NPI-Q) and the MBI-C.
Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score	Baseline	consistency will be assessed using Cronbach's alpha and McDonald's Omega coefficients.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Mild Behavioral Impairment (MBI) in memory center patients presenting mild cognitive impairment (MCI) or a subjective cognitive complaint (SCC).	Baseline	Percentage of patients having the 4 items of the MBI diagnostic criteria of the International Society to Advance Alzheimer's Research and Treatment (ISTAART)
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	The best diagnostic threshold for MBI-C will be determined using the receiver operating characteristic (ROC) curve using as a reference the diagnosis by 4 items of the MBI diagnostic criteria of the ISTAART

Trial Locations

Locations (5)

University Hospital Limoges; 🇫🇷 Limoges, France

Univsersity Hospital Lyon; 🇫🇷 Villeurbanne, France

University Hospital Nice; 🇫🇷 Nice, France

University Hospital Strasbourg; 🇫🇷 Strasbourg, France

University Hospital Toulouse; 🇫🇷 Toulouse, France