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: Not yet recruiting
• Conditions: Bipolar Disorder; Behavioral Variant of Frontotemporal Disorder (bvFTD); Phenocopy Frontotemporal Dementia (phFTD); Frontal Variant of Alzheimer Disease
• Intervention / Treatment: Other: Submission of the NEO-PI-3 questionnaire; Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)

• Study Type: Observational
• Enrollment (Estimated): 120

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted among eligible patients with bvFTD, fvAD, phFTD, followed to Memory Resource and Research Centre at Nantes university Hospital CMRR or referred to the department for a neuropsychological assessment (bipolar disorder). It will prospectively enroll 120 participants.

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?

Number of groups / cohorts

4

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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premorbid personality traits	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)	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: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: bvFTD; fvAD; phFTD; bipolar disorder,personality
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Tauopathies; Bipolar and Related Disorders; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Alzheimer Disease; Bipolar Disorder; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: RC23_0343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No