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Wednesday, February 10, 2010 11:13:26 PM
More recent data are however, a little puzzling for me. One would expect the placebos to perform at least a little better at 12 months compared to historical controls as the use of AChI in the recent trials is around 90%.
Data from the large Flurizan 18 months P3 study showed greater than expected cognitive decline at 12 months of 4.2 points. Bear in mind that most of the patients have been on one of the approved AChI therapy. One caveat: the ADASCog used in this study had an 80 point scale as opposed to a standard 70 points. On the other hand, patients had exclusively mild AD. This should more than even out the disproportion of usinf a slightly different scale since mild patients decline less over the short term. On the functional endpoint (ADCS-ADL) patients declined by 6 points, which corresponds to a 5.5 decline seen in Dimebon placebos at 12 months. This seems to me also rather high as I would expect at least some Aricept efficacy on ADL at 12 months.
Data from the Elan/Wyeth small subgroup analysis are even more suspect. Placebos fell like a rock at 12 month to more than 6 ADAScog points below baseline despite being on a concomitant AChI treatment. On a functional endpoint (DAD) the decline was about 9 points. This looks to me also a tad higher than historical controls.
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