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.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01325662
First received: March 28, 2011
Last updated: August 21, 2013
Last verified: August 2013

March 28, 2011
August 21, 2013
March 2011
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01325662 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Use of an Indwelling Catheter to Obtain Cerebrospinal Fluid (CSF) by Low-rate Continuous Sampling (MK-0000-211)
A Clinical Study to Evaluate a Modified Serial CSF Sampling Method by Indwelling Lumbar Catheter in Healthy Volunteers

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Cerebrospinal fluid (CSF)

Non-Probability Sample

Healthy volunteers from general population

Alzheimer's Disease
Not Provided
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01325662
0000-211
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP