Subjective Cognitive ComplaintMBI-CNCT06516159
Validation of the MBI-C Scale in French
An observational study of Subjective Cognitive Complaint and Mild Cognitive Impairment, run by University Hospital, Toulouse at 5 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subjective Cognitive Complaint, Mild Cognitive Impairment, Neuropsychiatric Symptoms
- What is being tested?
- MBI-C Scale in French
- How many people
- 170 participants
- Where
- 5 sitesFrance
- Study dates
- 26 Jun 2023to 17 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
University Hospital Limoges
Limoges, 87042
University Hospital Nice
Nice, 06100
University Hospital Strasbourg
Strasbourg, 67091
University Hospital Toulouse
Toulouse, 31059
Univsersity Hospital Lyon
Villeurbanne, 69100
About this study
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).
Read the 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.
- Being tested
- MBI-C Scale in French
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBI-C Scale in FrenchDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| MBI-C Scale in French | Not described Receives: Diagnostic Test: MBI-C Scale in French |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score
consistency will be assessed using Cronbach's alpha and McDonald's Omega coefficients.
Measured: Baseline
External validation of the Mild Behavioral Impairment-Checklist score
Comparison of differences between the scores of the five domains of the NeuroPsychiatric Inventory-Total Questionnaire (NPI-Q) and the MBI-C.
Measured: Baseline
Secondary outcomes (2)
Prevalence of Mild Behavioral Impairment (MBI) in memory center patients presenting mild cognitive impairment (MCI) or a subjective cognitive complaint (SCC).
Percentage of patients having the 4 items of the MBI diagnostic criteria of the International Society to Advance Alzheimer's Research and Treatment (ISTAART)
Measured: Baseline
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).
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start26 Jun 2023
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive ComplaintStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria SOTO, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516159
- Sponsor's protocol ID
- RC31/22/0323
- Acronym
- MBI-C
- Status last verified
- Apr 2025
- First submitted
- 11 Jul 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the MBI-C Scale in French
- ClinicalTrials.gov ID
- NCT06516159
- Acronym / sponsor ID
- MBI-C / RC31/22/0323
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBI-C Scale in French | – | Diagnostic Test: MBI-C Scale in French |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBI-C Scale in FrenchThe 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. | Diagnostic test | MBI-C Scale in French |
Primary outcome
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.
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.
2 secondary outcomes
Prevalence of Mild Behavioral Impairment (MBI) in memory center patients presenting mild cognitive impairment (MCI) or a subjective cognitive complaint (SCC).
Time frame: Baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria SOTO principal investigator
University Hospital, Toulouse
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjective Cognitive Complaint and Mild Cognitive Impairment, run by University Hospital, Toulouse at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.