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NCT Number: NCT06059313

Premorbid Personality Profile of Patients With 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.

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Key information

Conditions

Behavioral Variant of Frontotemporal Disorder (bvFTD) Bipolar Disorder Bipolar and Related Disorders Frontal Variant of Alzheimer Disease Mental Disorders Mood Disorders Phenocopy Frontotemporal Dementia (phFTD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Submission of the NEO-PI-3 questionnaire

Other

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).

Submission of the Interpersonal Reactivity Index questionnaire (IRI)

Other

The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Claire BOUTOLEAU-BRETONNIERE, PH

CONTACT

[email protected]

33 2 40 16 54 22

Laetitia BARBIN

CONTACT

[email protected]

33 2 40 16 59 42

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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