NCT01325662已完成不适用
A Clinical Study to Evaluate a Modified Serial CSF Sampling Method by Indwelling Lumbar Catheter in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Increase in CSF Aβ40 levels as measured by the new low flow continuous drip sampling method
研究概览
简要总结
This is a study to evaluate the feasibility and tolerability of low-rate continuous Cerebrospinal Fluid (CSF) sampling and to estimate the number of participants who exhibit severe baseline instability of CSF amyloid beta isoform Aß40 concentrations in healthy participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Must be in good health
- •Must have a body mass index greater than or equal to 18 kg/m^2 and less than or equal to 30 kg/m^2
排除标准
- •Is pregnant, nursing, or plans to become pregnant
- •Has clinically significant cardiovascular, renal, hepatic, gastrointestinal (GI), neurological, endocrine, hematological, dermatological or metabolic disease, or clinically significant abnormalities, as determined by medical history, physical examination, electrocardiogram, vital signs, or laboratory tests
- •Has a history of migraine headaches
- •Has a history of recent lumbar CSF sampling within 3 weeks prior to screening, history of lumbar spine surgery, or chronic low back pain or injury
- •Has an infection or inflammation of the skin in or in close proximity to the area of the lumbar puncture site
- •Has a history of a seizure disorder
- •Is noted to have papilledema or clinically significant focal neurological deficits at the screening physical examination, as well as abnormalities of CSF pressure on initial testing once access to the lumbar space is achieved
- •Has absolute or relative anatomic abnormalities that would be a contraindication to lumbar puncture
- •Is a heavy consumer of alcohol
- •Has used nicotine in the past 6 months
- •Has a history of a significant psychiatric disorder
结局指标
主要结局
Increase in CSF Aβ40 levels as measured by the new low flow continuous drip sampling method
时间窗: Up to 24 hours
次要结局
- Increase in CSF Aβ40 levels as measured by the current intermittent drip sampling method(Up to 24 hours)
研究者
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