hi Southoz ...
Im not sure I agree here...
The IMAGINE group wasn't as homogenous as the team hoped it would be ... that was one of the first comments made in the CC when talking of interpreting results on cognition.
Secondly, the previous EURO trial already showed clearing of soluble amyloid in spinal fluid and congnition improvements, and the intent in IMAGINE was to see if the same clearing of amyloid in brain that could be detected in imaging - and what was known to date was that the placebo group should not show any significant decline in this scenario.. We also got a small peak in brain volume imaging that showed positive trends.
It would be nice to see an explanation regarding why the placebo group deviated more than the Prana team were expecting, but at the end of the day as long as they have garnered enough information to do a successful phase 3 ( which can gain financial support ) then IMAGINE hopefully has done its job in refining trial design to ensure we hit objectives in the RIGHT biomarkers as well as the required cognition benefits to take to the FDA
where is Skint?, page-37
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