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NCT Number: NCT06516159

Validation of the MBI-C Scale in French

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).

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Key information

Conditions

Subjective Cognitive Complaint Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Neuropsychiatric Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Limoges, Limoges, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline

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

  2. External validation of the Mild Behavioral Impairment-Checklist score

    Time frame: Baseline

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

Secondary outcomes

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

    Time frame: 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)

  2. 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).

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: MBI-C

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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