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"Most worryingly, it turns out that there was a clear difference between the placebo group and the treatment group in APOE4 status." I would turn to Derek Lowe
by kurthr 8y ago
"Most worryingly, it turns out that there was a clear difference between the placebo group and the treatment group in APOE4 status."
I would turn to Derek Lowe as he is an expert in the field who has been looking forward to this release... he holds out hope, but is not positive on "the field is in the state it’s in today."
http://blogs.sciencemag.org/pipeline/archives/2018/07/26/biogen-and-eisai-let-the-alzheimers-arguing-commence http://blogs.sciencemag.org/pipeline/archives/2018/07/26/bio...
"APOE4, a lipoprotein, has been recognized as a risk factor for Alzheimer’s since back in the 1990s, although the mechanism behind that has been the subject of debate. But there was a regulatory-mandated change in enrollment of APOE4 patients during the (Bayesian) trial, for fear of a brain-swelling side effect that these patients are also prone to, and there ended up being far more APOE4-positive patients in the placebo group compared to the high-dose group (70% versus 30%)."
- aaavl2821 8y agoShould also note that the study missed its primary endpoint, but the companies decided to wait for the 18 month analysis anyway, and one dose seemed promising at this 18 month timepiint. Other doses did worse than placebo Other analysts who have been looking forward to the data and have digested it in detail have similar takes, others more positive: https://www.fiercebiotech.com/biotech/biogen-and-eisai-s-anti-amyloid-med-slows-alzheimer-s-decline-phase-2 https://www.fiercebiotech.com/biotech/biogen-and-eisai-s-ant... APOE4 status was an issue. Also the fact that two doses did worse than placebo was odd. And one of the measures of cognitive decline was a metric developed by the company, which could be concerning or could be valid, idk