Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of words remembered on Verbal learning task
研究概览
简要总结
The aim of the current project is to validate PDE4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will demonstrate whether memory, but also attention, information processing or executive function improves with the PDE4 inhibitor roflumilast 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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 35 years of age
- •Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
- •Body mass index between 18.5 and 30
- •Willingness to sign an informed consent.
- •Positive evaluation on the memory screening
排除标准
- •History of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness
- •First-degree relative with psychiatric disorder (in particular major depressive disorder and suicidality)
- •Excessive drinking (>20 glasses of alcohol containing beverages per week)
- •Pregnancy or lactation
- •Use of chronic medication other than oral contraceptives
- •Use of recreational drugs in the 2 weeks preceding participation
- •Orthostatic hypotension
- •Lactose intolerance
- •Sensory or motor deficits which could reasonably be expected to affect test performance
研究组 & 干预措施
roflumilast1000ug
干预措施: roflumilast (Drug)
roflumilast 300ug
干预措施: roflumilast (Drug)
roflumilast 100ug
干预措施: roflumilast (Drug)
placebo
干预措施: Placebo (Drug)
placebo
干预措施: roflumilast (Drug)
结局指标
主要结局
Number of words remembered on Verbal learning task
时间窗: 1hr after drug intake
30 monosyllable words will be displayed on a computer screen. Immediately after the presentation and after 45 minutes, subjects will be asked to report as much words as they remember. In addition, a recognition trial is conducted. Here, 30 words will be presented; 15 new words and 15 from the original list. Subjects have to indicate whether the word is old or new.
次要结局
未报告次要终点