Healthy
Conditions
Keywords
Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker
Brief summary
The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.
Interventions
OTHERSampling Rate
Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multiple Exploratory Biomarkers | Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours) |
Countries
United States
Outcome results
None listed