TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Phase 1

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00203359
• Lead Sponsor: Tobinick, Edward Lewis, M.D.

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2006-04
• Study Completion: 2006-04
• Last Update Submitted: 2006-04-20
• Last Update Posted: 2006-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ADAS-Cog
MMSE
SIB

Secondary Outcome Measures

Name	Time	Method
other neuropsychological tests
Category fluency

Trial Locations

Locations (1)

Edward Tobinick, MD (private medical office); 🇺🇸 Los Angeles, California, United States