Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers

NCT ID: NCT01126567

Last Updated: 2010-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-02-28

Brief Summary

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The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High Sampling Rate

Samples will be obtained at a high rate

Sampling Rate

Intervention Type OTHER

Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.

Low Sampling Rate

Samples will be obtained at a low rate

Sampling Rate

Intervention Type OTHER

Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.

Interventions

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Sampling Rate

Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age is between 18 and 50 years, inclusive
* Judged to be in general good health based on medical history, physical exam, neuro exam, vital signs, lab profile and ECG

Exclusion Criteria

* Positive urine drug screen for drugs of abuse
* History of bleeding disorder or deep vein thrombosis
* History of migraine or other types of headache more than twice/month, history of spinal disc disease or chronic significant low back pain
* Use of blood thinning compounds within 10 days of lumbar drain placement
* Finding on head CT that contraindicates lumbar puncture
* History of spinal surgery
* Use of tobacco/nicotine containing products within 6 month period prior to initial lumbar drain placement
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Robert Lenz, M.D., Ph.D.

Role: STUDY_DIRECTOR

Abbott

Locations

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Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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F09-113

Identifier Type: -

Identifier Source: org_study_id

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