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TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00203359
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 24, 2006
Sponsor:
Information provided by:
Tobinick, Edward Lewis, M.D.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: etanercept given by perispinal administration Phase 1

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Etanercept for Alzheimer's-Type Memory Loss Pilot Study
Study Start Date : September 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. ADAS-Cog
  2. SIB
  3. MMSE

Secondary Outcome Measures :
  1. Category fluency
  2. other neuropsychological tests

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NINCDS-ADRDA Criteria for Alzheimer's disease
  • CT or MRI consistent with AD

Exclusion Criteria:

  • active infection
  • CHF
  • demyelinating disease
  • uncontrolled diabetes mellitus
  • vascular dementia
  • clinically significant neurologic disease other than AD
  • Hachinski >4
  • history of lymphoma
  • TBC
  • wbc<2500
  • platelets<100,000
  • HCT<30
  • pregnancy
  • premenopausal, fertile not on acceptable birth control
  • change in neuroactive medication within 4 weeks of study initiation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203359


Locations
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United States, California
Edward Tobinick, MD (private medical office)
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Tobinick, Edward Lewis, M.D.
Investigators
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Principal Investigator: Edward L Tobinick, MD unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)
More Information
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ClinicalTrials.gov Identifier: NCT00203359    
Other Study ID Numbers: 10005
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 24, 2006
Last Verified: April 2006
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors