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Page 4 Page 1 - 2 - 3 - 5 - 6 - 7 - 8 - 9 - 10 - 11 - 12 - 13 The first three placebo arms of the Net-PD trial resulted in progression rate and in total UPDRS change per year, of unmedicated patients, ranging from 5.6 to 7.1. Remember these are supposed to provide a 30 percent improvement as compared to the placebo. And the placebo?
Looks like one placebo is not the same as another placebo. This illustrates the futility of a $60 million trial based on this kind of measurements. The Holy Grail would be a biological measurement of progression that is objective, repeatable and rock solid. We don't have that. Partly we don't have that because it's complicated. Partly we don’t have that because in my opinion we don't work hard enough in proportion to the complication of the task. We can do better than comparison to another year's placebo trial. For example, Parkinson's disease is defined by movement disorder symptoms. You don't go in there and get a blood test and somebody tells you you have Parkinson's. You go look at tremor, you look at movements, and using a pseudo-objective questionnaire. If we measure a movement by observation, why can’t we measure movement objectively, in this era of cars that Dr. Morrison doesn’t know how to . . [Laughter] . . . turn on. By the way, the key word is when it doesn’t work, reboot it. [Laughter]
The device looks like a little computer, with a microphone so you can test the voice pressure, it has a keyboard that you use to measure finger mobility, it has little pads that you can measure movement with. There was a clinical trial that was recently completed that measured the characteristics of tremor, limb bradykinesia, limb reaction time and movement time, fine motor bradykinesia and voice. The trial was completed. It was a multi-site trial. Excellent adherence. I think people actually liked using the device. I tried it and I don't understand why they like it but I also don't understand why people have spent time watching baseball. The compliance rate was excellent, people really stuck with this. And the first look at the data is pretty promising.
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Copyright © 2004-2007 Parkinson Pipeline Project. All rights reserved. Revised: 03/22/08. |