A Shot of Controversy: Bogus or Breakthrough? -- Research Summary

BACKGROUND: Alzheimer's disease (AD) is one of the most feared diagnoses. First discovered in 1906 by German physician Alois Alzheimer, the brain illness is progressive and deadly. According to the Alzheimer's Association, it is the sixth-leading cause of death in the United States with roughly five million people currently suffering from it. As the baby boomer generation ages, that figure is expected to reach 13.2 million in the next 50 years.

TREATMENT: There are currently two classes of medications approved by the Food and Drug Administration to treat AD. Cholinesterase inhibitors, like the drugs Aricept, Exelon and Razadyne, are prescribed for mild to moderate AD. They may help slow or prevent symptoms from worsening for a period of time and help control some behavioral symptoms. The other class of drugs for AD are glutamate inhibitors like Namenda, which are prescribed to treat moderate to severe AD. Because the two types of drugs work very differently, they may be used in combination. They are not normally administered to patients who have lost their ability to communication or care for themselves.

BREAKTHROUGH DRUG? One of the most talked about news in Alzheimer's disease last year was a drug that purportedly produces drastic results within just minutes of administering it. Edward Tobinick, M.D., director of the Institute for Neurological Research in Los Angeles, Calif., is injecting etanercept -- a drug approved to treat arthritis -- through the neck of AD patients and into their spine. Difficulties in language function are a symptom often experienced by AD patients. According to Dr. Tobinick, the drug can rapidly improve language abilities. "What we see is an improvement in their ability to think and calculate," Dr. Tobinick was quoted as saying. "Their verbal ability improves, they find words easier, they seem happier, and we often also see an improvement in gait in those patients whose gait is affected."

Dr. Tobinick says the drug works by targeting tumor necrosis factor-alpha (TNF-alpha), a protein critical to the brain's immune system. TFN-apha regulates neural impulse transmission, but researchers believe in Alzheimer's disease, increased levels hinder that regulation and interfere with memory processes. TNF levels have been found to be up to 25-times higher in the fluid surrounding Alzheimer's patients' brains. Specifically, excess TNF-alpha increases amyloid production which in turn induces TNF-alpha. The unique perispinal delivery of etanercept allows the drug to enter the brain and block the TNF-alpha disruption, study authors said.

CONTROVERY: Amgen, the maker of ENBREL, the marketed version of etanercept, does not back the drug as a treatment for AD. A statement published on their Web site reads, "This off-label, unapproved treatment, administered by Dr. Edward Tobinick, is not supported nor endorsed by Amgen." The company notes a lack of scientific data to support ENBREL as an Alzheimer's therapy. "While Amgen and others have long recognized the potential role of inflammation in neurological conditions, we have carefully examined these reports and believe that there is insufficient and unsubstantiated scientific data to support the use of ENBREL as a means of treating Alzheimer's disease."

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Melissa Medalie at mmedalie@ivanhoe.com.

FOR MORE INFORMATION, PLEASE CONTACT:

http://www.nrimed.com
http://www.enbrel.com