Clinical trial NCT06516159: Validation of the MBI-C Scale in French
Official title: Validation of the MBI-C Scale in French
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjective Cognitive Complaint
Mild Cognitive Impairment
Neuropsychiatric Symptoms
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 170
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score
timeFrame: Baseline
measure: External validation of the Mild Behavioral Impairment-Checklist score
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of Mild Behavioral Impairment (MBI) in memory center patients presenting mild cognitive impairment (MCI) or a subjective cognitive complaint (SCC).
timeFrame: Baseline
measure: 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).
timeFrame: Baseline
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital Limoges
city: Nice
country: France
facility: University Hospital Nice
city: Strasbourg
country: France
facility: University Hospital Strasbourg
city: Toulouse
country: France
facility: University Hospital Toulouse
city: Villeurbanne
country: France
facility: Univsersity Hospital Lyon
Study officials:
affiliation: University Hospital, Toulouse
name: Maria SOTO
role: PRINCIPAL_INVESTIGATOR
References: