Researchers at Alzheimer’s.org estimate that 45-60% of people diagnosed with AD have the Apoe-4 gene, which causes me to wonder whether my mother who died in 2000 from bed-ridden AD, unable to recognize either my brother or me, had that gene. Two falls with pelvic bone breakage and resultant inability to walk her usual 2 miles/day at age 86 contributed, no doubt.
Much appreciated. It does seem like this is possible. FDA could grant accelerated approval, but conditional on Amarin launching a larger outcomes trial. I think that would be the best case scenario here. We'd probably need a larger outcomes trial anyway for EMA/European approval.
"Lilly had applied for accelerated approval last year based on findings from a small mid-stage study of around 250 people with Alzheimer’s, half of whom received donanemab. The study showed treatment with the drug eliminated toxic clumps of a protein known as amyloid that’s long been seen as central to Alzheimer’s disease. Encouragingly, results also indicated that patients on donanemab declined more slowly than those on a placebo."
Donanemab was eventually approved based on the TRAILBLAZER-ALZ 2 (N=1800).
NS...Thanks for this article...Amyloid deposition in the brain is a well recognized symptom of AD...It may precede recognized cognitive damage...The challenge is to reduce the new formation of amyloid or, at least, to inhibit it....while at the same time minimizing the decay of cognitive facilities.
Patience will be necessary...When I recommended Vascepa to a family member with established AZ it was quickly discontinued because the patient and his family did not see an immediate improvement in his cognition.
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