Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Amyloid beta
研究概览
简要总结
Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta). Recent animal studies have shown that extended wakefulness is associated with increased production of these Abeta proteins and that sleep leads to a marked fall in their production.
Aim: The investigators aim to distinguish a similar effect of sleep disturbance on cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as an important factor in AD development.
Methods: a study in 26 healthy male volunteers, measuring CSF Abeta levels during a sleep deprivation night and before and after a control night with unrestricted sleep.
Expected results: The investigators expect sleep deprivation to lead to an increase in CSF Abeta levels, as compared to the levels in the control night.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age 40-60 years
- •Subject is in good health as established by medical history, physical examination, ECG and laboratory examination
- •Laboratory parameters (as described on in section 3.7 screening) should be within the normal ranges as applicable in RUNMC, Nijmegen, or clinically acceptable to the investigator
- •Normal sleep behaviour, Pittsburg Sleep Quality index score ≤5
- •MMSE 28 or higher
- •Medication free
排除标准
- •Presence of blood coagulopathy, established by medical history
- •Allergy to local anesthetic agents
- •Contra-indication for spinal catheter placement: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine
- •Subjects who are currently participating in another study or have participated in a clinical study within 30 days, based on their own report about participation history
- •Subjects with a history of drug or alcohol abuse
- •Subjects who are part of the study staff personnel or family members of the study staff personnel
结局指标
主要结局
Amyloid beta
时间窗: 6 timepoints during one night of sleep deprivation
Subjects will undergo one night of sleep deprivation before, during and after which a total of 9 CSF samples (6ml each) will be drawn through a spinal catheter. From these CSF samples Amyloid beta will be analysed.
次要结局
未报告次要终点
研究者
Dr. J. Claassen
Dr. Jurgen Claassen
University Medical Center Nijmegen