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临床试验/NCT06059313
NCT06059313招募中不适用

Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年12月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Premorbid personality traits

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Patient with no caregiver
  • Pregnant or breast feeding women

研究组 & 干预措施

Behavioral variant of frontotemporal disorder (bvFTD)

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

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

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.

干预措施: Submission of the NEO-PI-3 questionnaire (Other)

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.

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

Frontal variant of Alzheimer disease

A group of participants who fulfill Ossenkopele criteria (2022)

干预措施: Submission of the NEO-PI-3 questionnaire (Other)

Frontal variant of Alzheimer disease

A group of participants who fulfill Ossenkopele criteria (2022)

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

Bipolar disorder

A group of participants who fulfill CIM 10 criteria

干预措施: Submission of the NEO-PI-3 questionnaire (Other)

Bipolar disorder

A group of participants who fulfill CIM 10 criteria

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

Behavioral variant of frontotemporal disorder (bvFTD)

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

干预措施: Submission of the NEO-PI-3 questionnaire (Other)

结局指标

主要结局

Premorbid personality traits

时间窗: 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.

次要结局

  • Interpersonal Reactivity Index (IRI)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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