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Changing horses (endpoints) midstream (trial)? Discussing rationale for LLY's changing the EXPEDITION3 study from co-primary endpoints of change in cognition and function to just cognition.Ticker(s): LLY, BIIB
Name: Dr Paul Aisen - MD
- Founding Director of USC Alzheimer's Therapeutic Research Institute
- Designed and directed multicenter therapeutic trials and had led basic research studies on therapeutic targets and biomarkers
- Has conducted therapeutic research on Alzheimer’s disease for the past two decades; has published extensively in peer reviewed journals
Please discuss the findings of this study looking at cognitive and functional progression during this 18 month study.
In light of this study, how much better understood is the course of disease in Alzheimer's understood?Added By: joe_mccann
Why do you think the FDA was reluctant to embrace this study design change? Do you think it was due to a lack of robustness in the data or more a clinical trial integrity issue.
Do other Alzheimer trials have supporting evidence of what was seen in this study? Has that analysis been published anywhere?
Based on the changes to EXPEDITION3 how does that impact your view of solanezumab's chances for success?
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