NCT06516159

Validation of the MBI-C Scale in French

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 170 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subjective Cognitive Complaint
• Mild Cognitive Impairment
• Neuropsychiatric Symptoms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MBI-C Scale in French	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.

Timeline

• Start date: 2023-06-26
• Primary completion: 2024-10-17
• Completion: 2024-10-17
• First posted: 2024-07-23
• Last updated: 2025-04-10

Locations

5 sites across 1 country: France