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Reversal of Alzheimer's Cognitive Decline By New Treatment Suggested in Small Human Pilot Study; Peer-Reviewed Study Published By Medscape General Medicine

Posted on: Friday, 28 April 2006, 12:00 CDT

Unprecedented results using a new way to treat Alzheimer's Disease (AD) were published this week in the neurology section of the peer-reviewed journal, Medscape General Medicine. The article presents the results of a six-month open-label, uncontrolled pilot study in which 15 patients with AD ranging in severity from mild to severe received weekly perispinal injections of a medication designed to reduce excess levels of tumor necrosis factor (TNF). TNF is a molecule which initiates and amplifies the inflammatory response in the brain and other organ systems.

Dr. Edward Tobinick, Assistant Clinical Professor of Medicine, UCLA, was lead author of the study with co-authors Dr. Hyman Gross, Clinical Professor of Neurology at USC, Dr. Hart Cohen, Associate Clinical Professor of Neurology, UCLA, and Dr. Alan Weinberger, Associate Clinical Professor of Medicine/Rheumatology, UCLA. All of the physicians are in full-time private practice in West Los Angeles.

The pilot study discussion includes in-depth analysis of how this innovative method of anti-TNF treatment may reduce inflammation in the AD brain. An increasing body of research points to inflammation as a critical factor in the pathophysiology of Alzheimer's. Previous work by Elizabeth Tarkowski and her colleagues at the University of Goteborg in Sweden documented levels of TNF 25 times elevated in the cerebrospinal fluid (the fluid surrounding the brain) in patients with AD.

The medication used, etanercept, is FDA-approved for treating rheumatoid arthritis and related conditions, but is off-label for treating AD. A previous pilot study for AD utilizing conventional methods of administration of etanercept, performed at the University of Nebraska, was unsuccessful, which may be explained by the fact that large molecules, such as etanercept, have been shown to be unable to cross the blood-brain barrier when administered systemically, i.e. abdomen or thigh. The authors hypothesize that the new method of perispinal administration used in the new study was responsible for the improvement noted and enabled etanercept to reach the brain in therapeutic concentration via the cerebrospinal venous system(1). The new study suggests that perispinal etanercept may have the potential to improve cognition when added to standard therapy consisting of memantine and/or a cholinesterase inhibitor, but further controlled study will be required to confirm the results of this small pilot study.

Dr. Gross noted, "So far, this appears to be the most effective treatment for the reversal of some of the major symptoms of Alzheimer's disease. I have recommended that my patients continue on this treatment, as without it they continue to cognitively decline. Alzheimer's disease can be as devastating as any cancer and represents a global medical crisis. Large-scale clinical trials should begin immediately to define its most appropriate therapeutic use."

The full-study is available at www.medscape.com.

Further information is available at www.nrimed.com.

(1) See Edward Tobinick, MD, The Cerebrospinal Venous System: Anatomy, Physiology, and Clinical Implications, Medscape General Medicine 2006, Volume 8(1):53. Dr. Tobinick has been awarded several U.S. patents describing this treatment method, including 6,982,089 and 6,177,077.

Source: Business Wire

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