TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Etanercept for Alzheimer's-Type Memory Loss Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: etanercept given by perispinal administration

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 Type: Interventional
• Enrollment: 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Edward Tobinick, MD (private medical office)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
MMSE
ADAS-Cog
SIB

Secondary Outcome Measures

Outcome Measure
Category fluency
other neuropsychological tests

Collaborators and Investigators

• Sponsor: Tobinick, Edward Lewis, M.D.
• Investigators: Principal Investigator: Edward L Tobinick, MD, unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion: April 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): April 24, 2006
• Last Update Submitted That Met QC Criteria: April 20, 2006
• Last Verified: April 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 10005 (Other Identifier: CTEP)