TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Etanercept for Alzheimer's-Type Memory Loss Pilot Study II

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.

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.

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