Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 6:16 AM
Study NCT ID:
NCT01126567
Status:
COMPLETED
Last Update Posted:
2010-05-19
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, plasma, cerebrospinal fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-18', 'studyFirstSubmitDate': '2010-02-24', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multiple Exploratory Biomarkers', 'timeFrame': 'Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours)'}, {'measure': 'Multiple Exploratory Biomarkers', 'timeFrame': 'Day 1 (at 0, 1.2.3.4.5.6.7.8.9.10,12,14,16,18,20,22,and 24 hours)'}]}, 'conditionsModule': {'keywords': ['Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age is between 18 and 50 years, inclusive\n* Judged to be in general good health based on medical history, physical exam, neuro exam, vital signs, lab profile and ECG\n\nExclusion Criteria:\n\n* Positive urine drug screen for drugs of abuse\n* History of bleeding disorder or deep vein thrombosis\n* History of migraine or other types of headache more than twice/month, history of spinal disc disease or chronic significant low back pain\n* Use of blood thinning compounds within 10 days of lumbar drain placement\n* Finding on head CT that contraindicates lumbar puncture\n* History of spinal surgery\n* Use of tobacco/nicotine containing products within 6 month period prior to initial lumbar drain placement'}, 'identificationModule': {'nctId': 'NCT01126567', 'briefTitle': 'Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Study of the Effects of Sampling Rate on Cerebrospinal Fluid (CSF) Biomarker Levels in Healthy Subjects', 'orgStudyIdInfo': {'id': 'F09-113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High Sampling Rate', 'description': 'Samples will be obtained at a high rate', 'interventionNames': ['Other: Sampling Rate']}, {'label': 'Low Sampling Rate', 'description': 'Samples will be obtained at a low rate', 'interventionNames': ['Other: Sampling Rate']}], 'interventions': [{'name': 'Sampling Rate', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['High Sampling Rate', 'Low Sampling Rate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Robert Lenz, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Daniel LLano, M.D., PhD, Associate Medical Director', 'oldOrganization': 'Abbott'}}}}