Jul 22 2008
New research into the treatment of Alzheimer's disease using a popular rheumatoid arthritis drug has caused some concern.
The research by the private medical group the Institute for Neurological Research in Los Angeles shows that Alzheimer's patients given the anti-inflammatory drug Enbrel (etanercept) appeared to have quite dramatic improvements in their speech.
In a small study involving 12 patients with Alzheimer's who were given the drug weekly for six months, a great improvement in language recall was seen shortly after treatment with Enbrel began.
Dr. Edward Tobinick, director of the Institute, who led the study, says the verbal effects are often seen within a few minutes of the first dose of the drug.
Dr. Tobinick, who invented and holds several patents on a special method of injecting the drug into the neck, charges between $10,000 and $40,000 per patient for the treatments.
A report and video on one patient released earlier in the year documents rapid language improvement within minutes of using the new treatment.
The disruption of language function, such as the ability to find words, is a common symptom in advancing Alzheimer's disease, and this is a new approach in treating such symptoms.
The research focuses on the effect of the anti-tumor necrosis factor–alpha (TNF-alpha) drug Enbrel on measures of verbal ability.
TNF-alpha is a critical component of the brain's immune system, and the researchers suggest that elevated levels of TNF-alpha in Alzheimer's disease interfere with this process.
Enbrel works by reducing these elevated TNF-alpha levels.
But some experts are uneasy with the research and say the early findings will raise premature hopes in patients and their families who may place undue value on this new dramatic finding.
Experts say the research does not provide independent confirmation and is not a true clinical trial and the true test must come from a more scientifically rigorous double-blind, placebo-controlled, randomized clinical trial, where patients receive either a dummy treatment or an active agent, and neither the doctor nor the patient knows which.
Dr. Tobinick acknowledges the study is limited because people knew they were getting the drug and says Alzheimer's patients in such open-label studies often show improvement.
He says the study provides evidence that "excess TNF, in the Alzheimer brain, may offer a new way to address this language dysfunction."
Enbrel is marketed by Amgen and Wyeth and Amgen too has expressed concern about the research, claiming there has been insufficient evidence so far.
Amgen says the 'off-label', unapproved treatment, administered by Dr. Edward Tobinick, is not supported nor endorsed by the company.
The study is published in the journal BioMed Central BMC Neurology.
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