Jason Karlawish
speaker
1,378 appearances
5 recordings
1 series
first heard Feb 2021
last heard Dec 2023
Jason Karlawish’s voice in public audio — every appearance, attributed to the second.
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Fine um
I think in this study, uh in all these Alzheimer's studies
You have to have a primary endpoint because you're gonna spend your alpha, your power on that, you know, and your alpha.
But there are also secondaries that you want to look at.
And ideally you'd like to see all your primary and secondaries line up because it kind of points you in the direction that there's something going on here.
So on the CPR sum of boxes.
The placebo group didn't decline very fast in this group as we'd expected, but the drug group declined slower than the placebo group.
And if you do, there are various machinations, and I I said that me i the way they analyzed the data, which is an entirely appropriate intention to treat, showed an overall mean difference of point four five on the C DR Summer boxes between drug and placebo.
That's the that's the effect size.
That's right.
So they measured again pretty s you could debate.
uh the the particulars of each measure, but they measured a series of standard measures of cognition, instrumental activities of daily living, a kind of a composite measure of cognition and instrumental activities of daily living.
And on all those measures of cognition and function, the same results were obtained, which was people on drug did not decline with the same rate as people on placebo.
So
Yeah, we are I'm not in a rut because if what if FDA approves the drug and I think they probably will unless there's some data that's gonna come out that when reanalysis shows, but it FDA will approve the drug.
If they approve the drug
I'll prescribe it at the Penn Memory Center.
It's going to be an interesting discussion because the drug and we'll talk about it does have risks and I think there's some subgroups that need to be thought carefully about.
But on balance, I think it crosses the threshold of being a drug that's efficacious.
out they had a drug with risks.
Showing 561–580 of 1,378 · page 29 of 69
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