Wednesday, January 16, 2008

Alzheimer's Association statement on a newly published case study of Etanercept (Enbrel) for Alzheimer's

The Alzheimer's Association welcomes new ideas for Alzheimer therapies, such as this. But we are concerned that, in their strong desire for more effective therapies, people with Alzheimer's and their families may place undue value on this new finding based on the dramatic language used in its description and the apparent immediate effect. Special care needs to be taken when investigating and discussing drugs already on the market in order that they are not prescribed nor made available inappropriately based on preliminary findings and/or news media coverage.

This possible treatment strategy is very preliminary. This newly published case study is of one subject. In addition, one of the lead investigators has stock in the company that produces the drug and has a number of patent positions in the area. All of this strengthens the need for independent confirmation to establish this finding.

Before this drug can become an accepted therapy for Alzheimer's disease, it would need to go through the FDA approval process, including randomized, blinded clinical trials. We need to see clinical studies in large, diverse populations. We need to see work in other laboratories by scientists without financial interest in the product. These things are only possible — for this and other potential therapies — if we have more resources available to the fight against Alzheimer's.

In addition, the nature of the drug delivery technique used in this research (injection by needle into the spine at the back of the neck, followed by a brief period with the head lowered and feet elevated) will make it very unlikely for long-term success, though it is an interesting possibility for proof of concept. This is potentially riskier than intravenous administration, a point worth noting for potential trial subjects. This route is not ideal for a medication for Alzheimer's.

This was not a registered, controlled clinical trial, and clinicians should not take this report as grounds for off-label use of Enbrel for Alzheimer's. Moreover, cervical intrathecal injections carry more risk than routine lumbar punctures. Clinical trials of Enbrel delivered by this method should only be undertaken by investigators specially trained in safe administration of injection via this route (i.e., anesthesiologists or neurosurgeons).

3 comments:

Joanne D. Kiggins said...

It would be wonderful if a drug is found that would wipe out Alzheimer's. Even if this drug undergoes the required studies and testing and is approved by the FDA, it's kind of scary to have a drug injected right into the spine.

flintysooner said...

Everyone I know has sent me a link about that study. I had already read about it though. The one patient killed it for me. Thanks for posting this.

~Betsy said...

I think this is a step in the right direction, but I agree with Terry. One patient just isn't enough. I so hope the research continues. It terrifies me to think about the upcoming epidemic among baby-boomers.