Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patient with no caregiver

Pregnant or breast feeding women

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Submission of the NEO-PI-3 questionnaire

    Other intervention

    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 intervention

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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Behavioral variant of frontotemporal disorder (bvFTD)2 interventions
Group B: Phenocopy frontotemporal dementia (phFTD)2 interventions
Group C: Frontal variant of Alzheimer disease2 interventions
Group D: Bipolar disorder2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

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).

Time frame
Baseline

Other outcomes

Sponsors and contacts

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