Bapineuzumab: Speculation on Alzheimer's Drug

Contributed by: Dennis Fortier, President, Medical Care Corporation

Bapineuzumab is an Alzheimer's drug that is now in the final stage of FDA approval. We described the mechanism of Bapineuzumab in this earlier post.

No one can say with any degree of certainty if it will be approved or not, but as noted in an update provided by Fierce Biotech,  there has been an interesting development in the progress of the clinical trial.  The companies sponsoring the trial, Pfizer/Wyeth and J&J, amended the protocol last year to expand the study by several thousand research subjects.  This is a very costly move in terms of research investment and time required to conclude the study, and has led to much speculation as to why the trial was expanded.

A leading theory that makes lots of sense, is tied to the recently revised guidelines for diagnosing Alzheimer's disease.  Under the new guidelines, the presence of disease pathology can be recognized much earlier, when symptoms are much subtler, compared to the former standards.  This bodes well for more effective treatment.

However, the new guidelines also create a potential conundrum in terms of currently approved treatments.

The FDA has approved 4 drugs for treating Alzheimer's, but all of those approvals are based on the former definition of the disease, that requires a later stage of disease progression and more severe symptoms before the diagnosis can be made.  It is possible that the Bapineuzumab trial was initiated to demonstrate efficacy against the late stage disease that was defined in the old guidelines, but revised to demonstrate efficacy against an earlier stage of disease as defined in the revised guidelines.

Although the trial protocol was amended about a year before the new guidelines were released, a draft version of the revisions have been available and mounting industry consensus has been visible for quite some time.

If the drug works, and the trial sponsors can demonstrate that it works at very early stages of Alzheimer's, this could be a giant leap forward for the field.

7 comments :

  1. Have the 2009 trial problems been resolved? and is there a possibility of a Bapineuzumab trial in South Africa via my Neurologist (who does trials)?

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  2. re my comments re Bapineuzumab (anonymous):
    my email address is :waltr@eject.com

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  3. Regarding the inquiries above, the best source of information is through the trial sponsors. They can be contacted through the site for the trial, which is noted in this earlier post: http://www.braintoday.com/2009/05/bapineuzumab-phase-iii-trial.html

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  4. hello is this drug anywhere in phase three trial in india ? thanks niranjan

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  5. Dear Mumbaiblogger,

    This link (http://clinicaltrials.gov/ct2/show/study/NCT00676143?show_locs=Y#locn) has further information about the Bapineuzumab trial, including the 231 clinical sites for the trial. Unfortunately, none of them are in in India.

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  6. Well I think that all kind of medications created to fight alzheimer it's a excellent thing 'cause this disease affect many people.

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