Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- A comparison between dosing groups on performance on neurocognitive measures
研究概览
简要总结
In recent years, there has been increased focus on cognitive side effects of sleep-inducing medications that may contribute to unusual behavior during unexpected awakenings during the night. Concerns regarding these side effects have led to a class Food and Drug Administration (FDA) warning for all sleep-inducing medications. Almorexant is an experimental sleep-inducing medication in a new class of medications that is being extensively developed by multiple pharmaceutical companies. Medications in this class block wake/arousal centers in the brain that function with proteins called hypocretins. The goal of this study is to evaluate the impact on cognitive performance of almorexant vs. zolpidem (an approved sleep aid) or placebo.
详细描述
Up to 216 healthy volunteers will be enrolled to participate in the 10 day study. After screening procedures have been completed (at SFVAMC), Days 1 - 7 will take place in subjects' homes, where their sleep/wake activity will be monitored. Days 8 - 10 will take place at Moffitt Hospital. On Day 10, subjects will take one dose of either almorexant 100mg, almorexant 200mg, zolpidem 10mg, or placebo. Cognitive tests will be administered to subjects throughout Day 10. Subjects will return for follow-up safety labs within 5 - 12 days of dosing with study medication. Based on animal studies, it is anticipated that subjects who take almorexant will be less cognitively impaired than those who take zolpidem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects will receive a one-time dose of Placebo.
干预措施: Placebo (Drug)
Almorexant 100mg
Subjects will receive a one-time dose of Almorexant 100mg.
干预措施: Almorexant (Drug)
Almorexant 200mg
Subjects will receive a one-time dose of Almorexant 200mg.
干预措施: Almorexant (Drug)
Zolpidem
Subjects will receive a one-time dose of Zolpidem 10mg.
干预措施: Zolpidem 10mg (Drug)
结局指标
主要结局
A comparison between dosing groups on performance on neurocognitive measures
时间窗: Within a 7-hour window post dose.
次要结局
未报告次要终点
研究者
Thomas C. Neylan, M.D.
Principal Investigator
Northern California Institute of Research and Education