- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06059313
Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders
Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders
Damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of Alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. Symptoms vary both quantitatively and qualitatively from disease to another and from person to person. It cannot be completely excluded that in some cases, factors of susceptibility such as premorbid personality traits lead to frontal fragility.
The study will assess the relationship between premorbid profile using NEO-PI 3 inventory and cognitive and behavioral/psychobehavioral manifestations in patients with behavioral variant of frontotemporal disorder (bvFTD), phenocopy frontotemporal dementia (phFTD), frontal variant of Alzheimer disease, bipolar disorder characterized with frontal damages.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Claire BOUTOLEAU-BRETONNIERE, PH
- Phone Number: 33 2 40 16 54 22
- Email: claire.boutoleaubretonniere@chu-nantes.fr
Study Contact Backup
- Name: Laetitia BARBIN
- Phone Number: 33 2 40 16 59 42
- Email: laetitia.barbin@chu-nantes.fr
Study Locations
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-
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Nantes, France
- Recruiting
- CHU de Nantes
-
Contact:
- Claire Bretonnière, PH
- Phone Number: 02 40 16 54 22
- Email: claire.boutoleaubretonniere@chu-nantes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria :
- Patients with behavioral variant of frontotemporal disorder (bvFTD) according to Rascovsky criteria (2011) or patients with phénocopy frontotemporal dementia (phFTD) who fulfill criteria for possible bvFTD and have no imaging abnormalities or patients with frontal variant of Alzheimer disease according to Ossenkopele criteria (2022), or patient with bipolar disorder according to CIM 10 criteria
- Score for Mini-mental state examination ≥ 18
- Patient with caregiver who has who has known him/her in the 10 years preceding the disease onset.
- Patient and caregiver consents (no opposition)
Exclusion Criteria :
- Patient with no caregiver
- Pregnant or breast feeding women
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Behavioral variant of frontotemporal disorder (bvFTD)
A group of participants who fulfill Rascovsky criteria (2011) for behavioural variant Frontotemporal Dementia
|
The questionnaire contains 240 statements.
For each statement, the patient chooses the answer that best corresponds to their choice (FD: strongly disagree - D: disagree - N: neutral - A: agree - FA: strongly agree).
The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others.
|
|
Phenocopy frontotemporal dementia (phFTD)
A group of participants who fulfill who fulfill Rascovsky criteria (2011) for possible behavioural variant Frontotemporal Dementia and have no imaging abnormalities.
|
The questionnaire contains 240 statements.
For each statement, the patient chooses the answer that best corresponds to their choice (FD: strongly disagree - D: disagree - N: neutral - A: agree - FA: strongly agree).
The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others.
|
|
Frontal variant of Alzheimer disease
A group of participants who fulfill Ossenkopele criteria (2022)
|
The questionnaire contains 240 statements.
For each statement, the patient chooses the answer that best corresponds to their choice (FD: strongly disagree - D: disagree - N: neutral - A: agree - FA: strongly agree).
The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others.
|
|
Bipolar disorder
A group of participants who fulfill CIM 10 criteria
|
The questionnaire contains 240 statements.
For each statement, the patient chooses the answer that best corresponds to their choice (FD: strongly disagree - D: disagree - N: neutral - A: agree - FA: strongly agree).
The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Premorbid personality traits
Time Frame: Baseline
|
Premorbid personality traits will be assessed by the NEO- NEO Personality Inventory-3 (NEO-PI-3).
The NEO PI-3 measures the five major domains of personality: Neuroticism, Extraversion, Openness to experience, Conscientiousness and Agreeableness.
Each domain is defined by 6 facets.
NEOPI-3 includes 240 items and responses are made on a 5-point Likert -type scale ranging from strongly Disagree to strongly agree.
The NEOPI 3 will be completed by a caregiver who has known the patient in the 10 years preceding the disease onset.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interpersonal Reactivity Index (IRI)
Time Frame: Baseline
|
IRI is a 28-item questionnaire measuring 4 aspects of empathy : perspective-taking, fantasy, empathic concern, personal distress.
Each answer is rated from 1 (does not describe me well) to 5 (describes me very well).
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC23_0343
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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