Contributed by: Michael Rafii, M.D., Ph.D - Director of the Memory Disorders Clinic at the University of California, San Diego.
Dimebon may soon become the next medication approved for AD. In my last blog, I described the long and arduous path taken by any new compound until it reaches patients. It looks like Dimebon is advancing down this road quite nicely. Pfizer, and its partner Medivation just announced initiation of a 12-month, Phase 3 clinical trial called CONCERT, which evaluates Dimebon plus Aricept for AD. Dimebon is thought to protect mitochondria of neurons damaged by AD, whereas Aricept works by boosting the cholinergic system, which is injured in AD.

What's interesting is that this Phase 3 program also includes the confirmatory 6-month CONNECTION study, which builds on results of the first pivotal trial of Dimebon alone and is the last step needed for FDA approval of Dimebon as monotherapy for AD.

Results of the first pivotal clinical trial of Dimebon in Alzheimer’s disease, published in the July 19, 2008 issue of The Lancet, showed that Dimebon improved the clinical course of Alzheimer’s disease. In this randomized, double-blind, placebo-controlled trial of 183 patients with mild-to-moderate Alzheimer’s disease, patients treated with Dimebon experienced statistically significant improvements compared to placebo in all the key aspects of the disease: memory and thinking, activities of daily living, behavior and overall function. After both six months and a full year of treatment, Dimebon-treated patients were significantly better than placebo-treated patients on all key aspects of the disease.

In January 2008, the FDA stated that only one more pivotal study is required to support the approval of Dimebon as monotherapy for AD. If the results are successful, as deemed by the FDA, neurologists will have one more option in their armamentarium for treating AD.

1 comment :

  1. Very interesting. I wonder if shares of the drug maker are up on this news.