TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Tobinick, Edward Lewis, M.D.
ClinicalTrials.gov Identifier:
NCT00203359
First received: September 12, 2005
Last updated: April 20, 2006
Last verified: April 2006
  Purpose

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.

  Eligibility

Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00203359

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

No publications provided

ClinicalTrials.gov 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014