Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Healthy Participants
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 in performance in episodic memory task as assessed by a picturial memory task between placebo and verum at two different timepoints
研究概览
简要总结
The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in healthy participants.
详细描述
Randomised, placebo controlled, double blind, cross-over design
Primary study outcomes are:
Performance in picturial and verbal memory tasks.
Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and motivation.
Once daily oral administration of placebo mannitol for 7 days in a cross-over trial with a washout period of at least 14 days between the two periods. Each participant will take triflusal as well as placebo
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
- •Male or female
- •Normotensive
- •BMI between 20 and 27 kg/m2
- •Aged between 18 and 40 years
- •Native or fluent German-speaking
- •Caucasian
- •Female practicing safe contraception
排除标准
- •Acute or chronic psychiatric or somatic disorder
- •Any contraindication against aspirin or other NSAIDS
- •History of coagulation disease
- •History of gastrointestinal disease
- •Laboratory exclusion criteria: values of blood count, blood chemistry and coagulation status outside normal range
- •Pathological ECG
- •Pregnancy, breast-feeding
研究组 & 干预措施
Verum/Placebo
This group will start with triflusal and after washout will receive placebo
干预措施: Triflusal (Drug)
Verum/Placebo
This group will start with triflusal and after washout will receive placebo
干预措施: Placebo (Drug)
Placebo/Verum
This group will start with placebo and will receive triflusal after washout.
干预措施: Triflusal (Drug)
Placebo/Verum
This group will start with placebo and will receive triflusal after washout.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in performance in episodic memory task as assessed by a picturial memory task between placebo and verum at two different timepoints
时间窗: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Picture task as described in (de Quervain, Kolassa et al. 2007). Number of correctly remembered pictures is counted.
Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points.
时间窗: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted.
次要结局
- Changes in depressive symptoms between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.)
- Change in performance in working memory task between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.)
- Mood state changes between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.)
- Change in anxiety symptoms between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.)
- Change in motivation between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.)
- Change in performance in a cognitive task between placebo and verum at two different time points.(Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.)
研究者
Prof. Dominique de Quervain, MD
Director
University of Basel