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

Alzheimer's Disease Clinical Trial

Official title:

A Clinical Study to Evaluate a Modified Serial CSF Sampling Method by Indwelling Lumbar Catheter in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325662
• Other study ID #: 0000-211
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: July 22, 2015
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in CSF Aß40 levels as measured by the new low flow continuous drip sampling method		Up to 24 hours	No
Secondary	Increase in CSF Aß40 levels as measured by the current intermittent drip sampling method		Up to 24 hours	No