Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders

Sponsor
Nantes University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059313
Collaborator
(none)
120
40

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Submission of the NEO-PI-3 questionnaire
  • Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Feb 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Behavioral variant of frontotemporal disorder (bvFTD)

A group of participants who fulfill Rascovsky criteria (2011) for behavioural variant Frontotemporal Dementia

Other: Submission of the NEO-PI-3 questionnaire
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).

Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)
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.

Other: Submission of the NEO-PI-3 questionnaire
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).

Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)
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)

Other: Submission of the NEO-PI-3 questionnaire
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).

Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)
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

Other: Submission of the NEO-PI-3 questionnaire
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).

Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)
The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others.

Outcome Measures

Primary Outcome Measures

  1. Premorbid personality traits [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.

Secondary Outcome Measures

  1. Interpersonal Reactivity Index (IRI) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT06059313
Other Study ID Numbers:
  • RC23_0343
First Posted:
Sep 28, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2023