TNF-Alpha Inhibition for Treatment of Alzheimer's Disease - Tabular View

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TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

This study has been completed.

Study NCT00203359. Last updated on April 20, 2006. Information provided by Tobinick, Edward Lewis, M.D.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Official Title ^†

Etanercept for Alzheimer's-Type Memory Loss Pilot Study

Brief Summary

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.

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary Outcome Measure ^†

ADAS-Cog
SIB
MMSE

Secondary Outcome Measure ^†

Category fluency
other neuropsychological tests

Condition ^†

Alzheimer's Disease

Intervention ^†

Drug: etanercept given by perispinal administration

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 2004

Completion Date

April 2006

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00203359

Organization ID

10005

Secondary IDs ^††

Study Sponsor ^†

Tobinick, Edward Lewis, M.D.

Collaborators ^††

Investigators ^†

Principal Investigator:

Edward L Tobinick, MD

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

Information Provided By

Tobinick, Edward Lewis, M.D.

Verification Date

April 2006

First Received Date ^†

September 12, 2005

Last Updated Date

April 20, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.