NCT02891343终止不适用
Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers WP1 P002 PHARMACOG
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery
研究概览
简要总结
The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development. In healthy volunteers, to test the reverse effect of symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment and cerebral activity changes by a challenge test. In this context, a transient hypoxia could be relevant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Good health on the basis of the medical interview, physical examination and standard biology parameters.
- •Right-Handed
- •Non-smoker
- •No cardiac nor pulmonary pathologies
- •No use of chronic treatment or psychotropic drugs or substances
- •BMI inferior to 25 Kg/m2
- •French speaker and able to understand the test instructions
- •Informed consent form signed
排除标准
- •Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor…) or retinal pathologies (including familial DMLA)
- •Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema
- •Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension
- •Subject with current chronic disease
- •Subject with vascular or metabolic risk factor
- •Subject with history of or current mental disease or addiction (MINI)
- •Subject with significant abnormality on biology
- •Subject with significant abnormality on ECG
- •Subject with significant abnormality on MRI
- •Subject with significant abnormality of electrical activities on EEG
- •Subject with family history of young onset dementia
- •Subject with family history of cardiac or pulmonary pathologies
- •Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
- •Subject with claustrophobia or contraindication to MRI
- •Subject under guardianship
- •Subject not covered by Social Security
- •Subject participating in another clinical trial
- •Subject with anxiety (STAI-Trait Score T> 51) or neuroticism personality (EPI Score N ≥13)
- •Subject bearded or refusing to shave
研究组 & 干预措施
Healthy volunteers
Experimental
干预措施: 2-hour period of hypoxia (Other)
结局指标
主要结局
the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery
时间窗: Between baseline (normoxic period) and Day 0 (hypoxia session )
次要结局
- The number of adverse events occuring during the period of hypoxia(at the baseline and after the hypoxia session (day0))
研究者
研究点 (2)
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