This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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. Identifier:
First received: March 28, 2011
Last updated: July 22, 2015
Last verified: July 2015
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.

Alzheimer's Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Secondary Outcome Measures:
  • 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)

Enrollment: 11
Study Start Date: March 2011
Study Completion Date: September 2011
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)
Intermittent sampling
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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01325662     History of Changes
Other Study ID Numbers: 0000-211
Study First Received: March 28, 2011
Last Updated: July 22, 2015

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on August 18, 2017