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

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

ADAS-Cog
SIB
MMSE
ADCS-ADLsev

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00203320 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Category fluency

Original Secondary Outcome Measures ^ICMJE

Same as current

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 II

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 30 study subjects for a period of one year with serial testing of cognition and function.

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

January 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

NCT00203320

Responsible Party

Study ID Numbers ^ICMJE

10007

Study Sponsor ^ICMJE

Tobinick, Edward Lewis, M.D.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Edward L. Tobinick, M.D.

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