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
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 April 17, 2014