A Study to Evaluate the Use of an Indwelling Catheter to Obtain Cerebrospinal Fluid (CSF) by Low-rate Continuous Sampling (MK-0000-211)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: March 28, 2011
Last updated: August 1, 2014
Last verified: August 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Clinical Study to Evaluate a Modified Serial CSF Sampling Method by Indwelling Lumbar Catheter in Healthy Volunteers
Primary Outcome Measures:
- Increase in CSF Aβ40 levels as measured by the new low flow continuous drip sampling method [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Increase in CSF Aβ40 levels as measured by the current intermittent drip sampling method [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
Cerebrospinal fluid (CSF)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
Continuous drip sampling
Sampling at ~0.6 cc / hour (~1.2 cc / 2 hours, or lowest feasible rate given technical requirements and volume requirements for core analytes assays)
Sampling at 4 cc every 2 hours (+ 2 cc dead space clearance, total = 6 cc / 2 hours)
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Healthy volunteers from general population
- 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
- 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
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ClinicalTrials.gov processed this record on March 26, 2015
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 28, 2011
||August 1, 2014
||United States: Institutional Review Board