NCT01599962已完成2 期
Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects
Prof. Dominique de Quervain, MD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of attention functions under cinacalcet
研究概览
简要总结
To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normotensive
- •native or fluent German-speaking
- •caucasian (European ancestry)
- •BMI between 19 and 27 kg/m2
排除标准
- •acute or chronic psychiatric or somatic disorder
- •pathological ECG
- •Low serum calcium
- •known hypersensitivity to the IMP
- •pregnancy
- •breast-feading
- •long-term medication within last 3 months
- •smoking more than 3 cigarettes per day
- •seizures in participants and first degree relatives
- •concurrent participation in another study
研究组 & 干预措施
Cinacalcet
Experimental
干预措施: Cinacalcet (Drug)
Sugar pill
Placebo Comparator
干预措施: Cinacalcet (Drug)
Sugar pill
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change of attention functions under cinacalcet
时间窗: two study days within 10 days
Change of memory functions under cinacalcet
时间窗: two testing days within 10 days
次要结局
- Change of emotional state under cinacalcet(two study days within 10 days)
研究者
Prof. Dominique de Quervain, MD
Director of the Division of Cognitive Neuroscience
University of Basel
研究点 (1)
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