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Sponsored by: |
Tobinick, Edward Lewis, M.D. |
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Information provided by: | Tobinick, Edward Lewis, M.D. |
ClinicalTrials.gov Identifier: | NCT00203359 |
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.
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: etanercept given by perispinal administration |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Etanercept for Alzheimer's-Type Memory Loss Pilot Study |
Estimated Enrollment: | 15 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | April 2006 |
Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 15 study subjects for a period of one month, followed by a 5 month and a 6 month possible study extension, with serial testing of cognition and function monthly.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Edward Tobinick, MD (private medical office) | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Edward L Tobinick, MD | unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA) |
Study ID Numbers: | 10005 |
Study First Received: | September 12, 2005 |
Last Updated: | April 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00203359 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Immunologic Factors Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases TNFR-Fc fusion protein Immunosuppressive Agents Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders |
Analgesics, Non-Narcotic Mental Disorders Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Dementia Amnesia Delirium |
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Gastrointestinal Agents Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases TNFR-Fc fusion protein Immunosuppressive Agents Pharmacologic Actions |
Delirium, Dementia, Amnestic, Cognitive Disorders Sensory System Agents Mental Disorders Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Dementia Tauopathies Central Nervous System Agents |