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Dimebon is looking good for Alzheimer's (AD). A 2nd AD trial (this one a PHASE 3) confirmed benefit seen in an earlier PHASE 2 trial. Benefits in memory, thinking, and behavior persisted during the year of treatment; in fact 81% of of AD participants were better than when they started the study. Based on these results Medivation is planning a larger PHASE 3 trial later this year. If results are positive, the company aims to start the FDA approval process in 2010 and the drug could move to patients shortly after. What about Huntington's; why was this trial slow to recruit?

The Huntington's Dimebon clinical trial started in July of 2007. Ninety participants drawn from 15 Centers of Excellence were to be enrolled for a 3 month trial. Nine months later in early March 2008, only 50 of the needed 90 participants have been enrolled. Why hasn't this gone more quickly? Look at it this way -- if enrollment had been completed efficiently -- we could have PHASE 2 results by now. Now at the end of March, enrollment has been completed. What a difference a month made!

Slow enrollment is a huge problem. The slower that HD recruitment goes, the longer it will take to get a successful drug to people. The entire community should be looking at this trial to identify problems that made recruitment slow initially, and the factors that sped it up this past month. And we need to correct recruitment errors as new trials for CoQ-10, creatine, and ACR-16 begin. And if trial participants aren't available to test them, it makes no difference how many new drugs are delivered down CHDI's pipeline.

Some of the Problems: Some Solutions

Motivation and Hope

And last but not least; it is important to allow hope. Because practically speaking, there will be no motivation to join a clinical trial without hope. There are those who tell me and other patient advocates that we should be more laid back, and to be careful how we transmit the enthusiasm we feel about recent advances in research and drug development. They say this because they don't want to give false hope. Certainly a failed drug trial disappoints HD people, but no more than the present no drug reality we live. When EPA failed, HD families were disappointed; but it took only a few days till we got back up and went on. Believe me it is far worse when "for our own good" we are not allowed hope.

Allow hope; it's good for drug development.