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frrol

05/30/20 10:14 PM

#253013 RE: Steady_T #253006

They're really both cognitive decline diseases and both have been trial tested using the CDR Continuity of Attention test. I think the decision to use it for our PDD trial was likely because it is commonly used in PDD, and that allows us to compare with other drugs' results. That's a very common and practical (if not obviously scientific) factor biotechs use for choosing endpoints. The MMSE, ADCS, and ADSCog are often used for Alzheimer's.

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nidan7500

05/31/20 8:31 AM

#253032 RE: Steady_T #253006

Steady T,
Quote:
[/quote]In the PPD case there is specific symptom that is expected to show improvement in the short study period.

Specifically "Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test."

The difference is there is a clear and easily quantifiable symptom that can be measured accurately with PDD. AD doesn't have any equivalent measure that is widely accepted at this point. We have seen some ECG response potential measurements early on in the AD research program but those have not made it into the trial protocols.[/quote]

The importance of this point cannot be exaggerated. Being able to obtain accurate and reproducible data from a trial of this type adds credibility and confidence to all involved and (IMO) may have been a factor in PDD as a "breakthrough" selection. Just an excellent point.

For example, by contrast the attached paper discusses the five year period involved in AD trials. We can read how the length of the trials and the uncertainty of results is bot expensive and ineffective for treatment development efforts. Even though they may not directly say so, one conclusion might be such lack of timely results has been a factor in the massive money and time spent on AD w/no progress.

https://www.sciencedirect.com/science/article/pii/S235287371830026X