TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

This study has been completed.

First Received: September 12, 2005 Last Updated: April 20, 2006 History of Changes

Sponsored by:	Tobinick, Edward Lewis, M.D.
Information provided by:	Tobinick, Edward Lewis, M.D.
ClinicalTrials.gov Identifier:	NCT00203359

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Etanercept

U.S. FDA Resources

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

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 06, 2009