TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

This study has been completed.

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

Sponsor:	Tobinick, Edward Lewis, M.D.
Information provided by:	Tobinick, Edward Lewis, M.D.
ClinicalTrials.gov Identifier:	NCT00203320

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:	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 II

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
ADCS-ADLsev

Secondary Outcome Measures:

Category fluency

Estimated Enrollment:	30
Study Start Date:	April 2005
Estimated Study Completion Date:	January 2006

Detailed Description:

Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 30 study subjects for a period of one year with serial testing of cognition and function.

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: NCT00203320

Locations

United States, California
100 UCLA Medical Plaza, Suites 205-210
Los Angeles, California, United States, 90095

Sponsors and Collaborators

Tobinick, Edward Lewis, M.D.

Investigators

Principal Investigator:

Edward L. Tobinick, M.D.

unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00203320 History of Changes
Other Study ID Numbers:	10007
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 February 09, 2012