Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00203320
Status:
COMPLETED
Last Update Posted:
2006-04-24
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2006-01'}, 'lastUpdateSubmitDate': '2006-04-20', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2006-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADAS-Cog'}, {'measure': 'SIB'}, {'measure': 'MMSE'}, {'measure': 'ADCS-ADLsev'}], 'secondaryOutcomes': [{'measure': 'Category fluency'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.', 'detailedDescription': 'Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 30 study subjects for a period of one year with serial testing of cognition and function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* NINCDS-ADRDA Criteria for Alzheimer's disease\n* CT or MRI consistent with AD\n\nExclusion Criteria:\n\n* active infection\n* CHF\n* demyelinating disease\n* uncontrolled diabetes mellitus\n* vascular dementia\n* clinically significant neurologic disease other than AD\n* Hachinski \\>4\n* history of lymphoma\n* TBC\n* wbc\\<2500\n* platelets\\<100,000\n* HCT\\<30\n* pregnancy\n* premenopausal, fertile not on acceptable birth control\n* change in neuroactive medication within 4 weeks of study initiation"}, 'identificationModule': {'nctId': 'NCT00203320', 'briefTitle': "TNF-Alpha Inhibition for Treatment of Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Tobinick, Edward Lewis, M.D.'}, 'officialTitle': "Etanercept for Alzheimer's-Type Memory Loss Pilot Study II", 'orgStudyIdInfo': {'id': '10007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'etanercept given by perispinal administration', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '100 UCLA Medical Plaza, Suites 205-210', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Edward L. Tobinick, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tobinick, Edward Lewis, M.D.', 'class': 'OTHER'}}}}