Status:
COMPLETED
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease
Lead Sponsor:
Tobinick, Edward Lewis, M.D.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
Phase:
PHASE1
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 potenti...
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...
Eligibility Criteria
Inclusion
- NINCDS-ADRDA Criteria for Alzheimer's disease
- CT or MRI consistent with AD
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00203359
Start Date
September 1 2004
End Date
April 1 2006
Last Update
April 24 2006
Active Locations (1)
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1
Edward Tobinick, MD (private medical office)
Los Angeles, California, United States, 90095