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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01325662

Enrollment

Registered

2011-03-30

Start date

2011-03-31

Completion date

2011-09-30

Last updated

2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Increase in CSF Aβ40 levels as measured by the new low flow continuous drip sampling method	Up to 24 hours

Secondary

Measure	Time frame
Increase in CSF Aβ40 levels as measured by the current intermittent drip sampling method	Up to 24 hours

Outcome results