TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Tobinick, Edward Lewis, M.D.

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: etanercept given by perispinal administration

Study type: Interventional

Funder types: Other

Identifiers

NCT00203359

10005

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)