.drwilner and Richard J. Caselli, MD, discuss developments in the treatment of Alzheimer's disease.
. Two monoclonal antibodies that are approved by the US Food and Drug Administration for the treatment of Alzheimer's disease.
The answer was that it helped a little. Now, you can be a glass-half-full or a glass-half-empty kind of person. To give you some specifics, in the aducanumab trials — without going into all the controversy of that — you'll recall that initially, Biogen, which sponsored those trials,after doing a futility analysis and concluding that aducanumab was really not clinically effective.
What is the CDR Sum of Boxes, and is 27% meaningful? CDR stands for Clinical Dementia Rating Scale. It's not something that you do in your office. It's not something I do in my office, although we do it in our research program as do other research centers. When we look at another trial, which you haven't mentioned because it hasn't been in the news because it hasn't hit its endpoints, was the gantenerumab trial. The gantenerumab trial was another monoclonal antibody directed against amyloid, this one delivered subcutaneously. It performed better in previous studies, but in the phase 3 trials, it didn't hit its endpoints.
It wouldn't surprise me if, at the end of all of this, this becomes kind of a winner-take-all, in that why would you do something every 2 weeks when you could do it once a month? Thinking about gantenerumab for a minute because there are trials looking at subcutaneous versions of some of these things, why would you do anything intravenously if you could do it subcutaneously at home? From the administration standpoint and the effectiveness standpoint, those are a couple of big considerations.
There are sex differences as well. Men seem to respond much better than women, but we don't know the reason. There are age differences. Older people over 75 seem to respond much better than younger people under 65. I don't really know why. If it came out that that's the only benefit, that's an answer for me. The trial may have been much more consistent, but a half a point out of 30 is not much.
Again, there's a large amount of history behind the amyloid cascade hypothesis and the strategy that led up to these studies and their results. I imagine between that momentum behind this whole strategy and, not to be ignored, the understandable vested interests of groups like the Alzheimer's Association, many people are looking for something.
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