A Study to Evaluate the Use of an Indwelling Catheter to Obtain Cerebrospinal Fluid (CSF) by Low-rate Continuous Sampling (MK-0000-211)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01325662
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : July 23, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease
Alzheimer's Disease

Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Study to Evaluate a Modified Serial CSF Sampling Method by Indwelling Lumbar Catheter in Healthy Volunteers
Study Start Date : March 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

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)
Intermittent sampling
Sampling at 4 cc every 2 hours (+ 2 cc dead space clearance, total = 6 cc / 2 hours)

Primary Outcome Measures :
  1. Increase in CSF Aβ40 levels as measured by the new low flow continuous drip sampling method [ Time Frame: Up to 24 hours ]

Secondary Outcome Measures :
  1. Increase in CSF Aβ40 levels as measured by the current intermittent drip sampling method [ Time Frame: Up to 24 hours ]

Biospecimen Retention:   Samples Without DNA
Cerebrospinal fluid (CSF)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers from general population

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01325662     History of Changes
Other Study ID Numbers: 0000-211
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders