Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers
Completed
- Conditions
- Healthy
- Interventions
- Other: Sampling Rate
- Registration Number
- NCT01126567
- Lead Sponsor
- Abbott
- Brief Summary
The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Age is between 18 and 50 years, inclusive
- Judged to be in general good health based on medical history, physical exam, neuro exam, vital signs, lab profile and ECG
Exclusion Criteria
- Positive urine drug screen for drugs of abuse
- History of bleeding disorder or deep vein thrombosis
- History of migraine or other types of headache more than twice/month, history of spinal disc disease or chronic significant low back pain
- Use of blood thinning compounds within 10 days of lumbar drain placement
- Finding on head CT that contraindicates lumbar puncture
- History of spinal surgery
- Use of tobacco/nicotine containing products within 6 month period prior to initial lumbar drain placement
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High Sampling Rate Sampling Rate Samples will be obtained at a high rate Low Sampling Rate Sampling Rate Samples will be obtained at a low rate
- Primary Outcome Measures
Name Time Method Multiple Exploratory Biomarkers Day 1 (at 0, 1.2.3.4.5.6.7.8.9.10,12,14,16,18,20,22,and 24 hours)
- Secondary Outcome Measures
Name Time Method