Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

This study has been completed.
Information provided by:
Tobinick, Edward Lewis, M.D. Identifier:
First received: September 12, 2005
Last updated: April 20, 2006
Last verified: April 2006

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
Alzheimer's Disease
Drug: etanercept given by perispinal administration
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Etanercept for Alzheimer's-Type Memory Loss Pilot Study

Resource links provided by NLM:

Further study details as provided by Tobinick, Edward Lewis, M.D.:

Primary Outcome Measures:
  • ADAS-Cog
  • SIB
  • MMSE

Secondary Outcome Measures:
  • Category fluency
  • other neuropsychological tests

Estimated Enrollment: 15
Study Start Date: September 2004
Estimated Study Completion Date: April 2006
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00203359

United States, California
Edward Tobinick, MD (private medical office)
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Tobinick, Edward Lewis, M.D.
Principal Investigator: Edward L Tobinick, MD unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)
  More Information

No publications provided Identifier: NCT00203359     History of Changes
Other Study ID Numbers: 10005
Study First Received: September 12, 2005
Last Updated: April 20, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
TNFR-Fc fusion protein
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2014