Do not trade this blog as 4 billion years of evolution is against me and possibly even God laughs at it, He has a great sense of humor!
Going Back To The Baseline
These are my first impressions from looking into the simufilam data released few days ago from the 12 months open label trial. The initial data for the 6 and 9 months included only 50 subjects. The current data includes 100 subjects. When the 9 months data was released a following illustration has been released. I took the libery and added the 12 months results to the graph. I hope that nobody will take it against me that I mix the 50 subject data and 100 subjects data.
It seems that the improvent on average has declined from the highs of -3.0 at 9 months. The more negative number denotes greater improvement. I looked at the illustration of performance of indivual patients as provided by $SAVA at the mark of 9 months, and I measured the individual performance then I recorded it spreadsheet to get averages for the 66% of patients $SAVA claimes that they improved.
The analysis was simple but tedious. So, the 66% patients who improved had average result of -6.0+/-7.13 ADAS-Cog11 (MMSE 2.57+/-3.1) points. When you look at the graph you can see the spread of data points to correspond visually to SD +/-7.13.
The 12 months data has has claimed that 63% of patients showed an inprovement with average score of -5.6+/-3.8 ADAS-Cog11 (MMSE 2.4+/-1.63). What is most conspicious here is the drop in the dispesion about the average after three more months. It means that the most improved patients have greater scores (less improved), and those at the borderline have improved somewhat as the Standard Deviation for that group of is cut in almost half. From this illustration, I mean the 9 months data, one can see that the 21% who did not dramatically declined seems to stay virtually the same as $SAVA reported them to have the average scores about 2.7+/-1.4 ADAS-Cog11. It seems that the drop in overall score has been disproportionally produced by reduction in the inprovement of the best performing patients.
I have two theories why this happened. The first thought coming to mind is that some of those paients are in the upper scores of ADAS-Cog11 and natural variability brought them to almost healthy level. The other is that the efficacy is just diminishing after the 9 months peak and the best scoring patients keep declining relatively quickly.
These results are rather disappointing as one would expect for a winning drug to better perform over such short time. The expacted drop in average scores for ADAS-Cog11 is about 5 points per year for natural progress of Alzheimer’s . With loss of 1.5 points per 3 months the drop over a year can be 5 points ADAS-Cog11. If we look at it that for 9 months we have improvenet and then we have 6 months of deterioration then on average this is delay of 1.25 years. Indeed it is a bit more than twice than the half year delay by Donezepil, but would it match the delay achieved by Blarcamesine? $AVXL will soon (few months) release the results from Alzheimer’s Phase 2b/3. Till then we have already done our work.
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