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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

April 20, 2006

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

ADAS-Cog
SIB
MMSE

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00203359 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Category fluency
other neuropsychological tests

Original Secondary Outcome Measures ^ICMJE

Category fluency

Descriptive Information

Brief Title ^ICMJE

TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: etanercept given by perispinal administration

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00203359

Responsible Party

Study ID Numbers ^ICMJE

10005

Study Sponsor ^ICMJE

Tobinick, Edward Lewis, M.D.

Collaborators ^ICMJE

Investigators ^ICMJE

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

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP