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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease

• Study Type: Observational
• Enrollment (Actual): 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers from general population

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 0000-211