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Validation of the MBI-C Scale in French

T

Toulouse University Hospital

Status

Completed

Conditions

Neuropsychiatric Symptoms
Subjective Cognitive Complaint
Mild Cognitive Impairment

Treatments

Diagnostic Test: MBI-C Scale in French

Study type

Observational

Funder types

Other

Identifiers

NCT06516159
RC31/22/0323

Details and patient eligibility

About

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).

Full 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.

Enrollment

170 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

170 participants in 1 patient group

MBI-C Scale in French
Treatment:
Diagnostic Test: MBI-C Scale in French

Trial contacts and locations

5

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Central trial contact

Maria SOTO

Data sourced from clinicaltrials.gov

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