TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Phase 1CompletedNCT00203359

Tobinick, Edward Lewis, M.D.15 enrolled

Overview

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 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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer's Disease

Interventions

etanercept given by perispinal administrationDRUG

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

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

Locations (1)

Edward Tobinick, MD (private medical office)

Los Angeles, California, United States

Outcomes

Primary Outcomes

ADAS-Cog

SIB

MMSE

Secondary Outcomes

Category fluency

other neuropsychological tests

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.