Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-24 @ 3:47 AM
Study NCT ID:
NCT06516159
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the MBI-C Scale in French
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score', 'timeFrame': 'Baseline', 'description': "consistency will be assessed using Cronbach's alpha and McDonald's Omega coefficients."}, {'measure': 'External validation of the Mild Behavioral Impairment-Checklist score', 'timeFrame': 'Baseline', 'description': 'Comparison of differences between the scores of the five domains of the NeuroPsychiatric Inventory-Total Questionnaire (NPI-Q) and the MBI-C.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of Mild Behavioral Impairment (MBI) in memory center patients presenting mild cognitive impairment (MCI) or a subjective cognitive complaint (SCC).', 'timeFrame': 'Baseline', 'description': "Percentage of patients having the 4 items of the MBI diagnostic criteria of the International Society to Advance Alzheimer's Research and Treatment (ISTAART)"}, {'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', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subjective Cognitive Complaint', 'Mild Cognitive Impairment', 'Neuropsychiatric Symptoms']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThe 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.\n\nThis 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.\n\nValidation of the MBI-C scale in French could play a crucial role in the identification and early management of neurodegenerative disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient presenting a subjective cognitive complaint (SCP) or mild cognitive impairment (MCI) for at least 6 months.\n* Patient with a relative visiting them at least once a week.\n* No opposition from the patient and his loved one\n\nExclusion Criteria:\n\n* Patient presenting criteria for major neurocognitive disorder according to DSM-V criteria.\n* Neuropsychiatric symptoms secondary to concomitant treatments, or to a medical or psychiatric pathology.\n* Concomitant major depressive episode (DSM-V).\n* Presence of concomitant pathologies preventing participation in the study (taking tests).'}, 'identificationModule': {'nctId': 'NCT06516159', 'acronym': 'MBI-C', 'briefTitle': 'Validation of the MBI-C Scale in French', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Validation of the MBI-C Scale in French', 'orgStudyIdInfo': {'id': 'RC31/22/0323'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MBI-C Scale in French', 'interventionNames': ['Diagnostic Test: MBI-C Scale in French']}], 'interventions': [{'name': 'MBI-C Scale in French', 'type': 'DIAGNOSTIC_TEST', 'description': 'The original version has 34 items, divided into 5 areas:\n\n* a reduction in motivation, interests and initiative\n* the appearance of mood disorders\n* dysregulation of impulse management\n* loss of conventions and societal norms\n* the abnormal development of strongly held beliefs and sensory experiences\n\nThe 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.\n\nThis 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.\n\nThe test lasts 10 minutes.', 'armGroupLabels': ['MBI-C Scale in French']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'University Hospital Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '06100', 'city': 'Nice', 'country': 'France', 'facility': 'University Hospital Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'University Hospital Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '69100', 'city': 'Villeurbanne', 'country': 'France', 'facility': 'Univsersity Hospital Lyon', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'overallOfficials': [{'name': 'Maria SOTO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}