NCT02843906Unknown不适用
Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Functionnal/Cognitive evaluation
研究概览
简要总结
The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of cognitive deficits in older patients with bipolar disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female subject aged between 60 and 80 years old
- •in patient or out-patient at one of the centers participating in the study
- •Mini-mental state examination (MMSE) score > 20 at baseline
- •patient with diagnostic of amnestic-Mild Cognitive Impairment
- •patients suffering of bipolar disorders type I or II
- •in remitted (euthymic) state at baseline
排除标准
- •pre-existing history of dementia
- •history of neurologic disorder
- •lifetime history of a severe psychiatric disorder other than bipolar disorders
- •current medical problems
- •patients treated with electroconvulsive therapy within the past six months
- •patients with substance abuse or dependence within the past 12 months
- •patients hospitalized without consent
结局指标
主要结局
Functionnal/Cognitive evaluation
时间窗: Half an hour
Global cognitive evaluation : MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL.
Brain MRI
时间窗: 40 minutes
Enable neuropsychological evaluation.
Psychatric evaluation
时间窗: 15 minutes
Semi-directive psychiatric interview.
次要结局
未报告次要终点
研究者
研究点 (2)
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