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CompletedNCT01325662Updated Jul 23, 2015

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

An observational study in Alzheimer's Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-23.

Sponsored by Merck Sharp & Dohme LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 11 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. Increase in CSF Aβ40 levels as measured by the new low flow continuous drip sampling method

    Time frame: Up to 24 hours

Secondary outcomes

  1. Increase in CSF Aβ40 levels as measured by the current intermittent drip sampling method

    Time frame: Up to 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01325662
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Mar 30, 2011
Start date
Mar 2011
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jul 23, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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