I’m definitely in agreement that this trial is barely better than a flop, but biogen will do everything they can to gain approval and sell billions of dollars worth to desperate families.
Consider that the 0.45 point higher score (on an 18 point scale) is barely better than the 0.35 point difference seen for aduhelm. Still around 20% of participants had brain edema on imaging (although less were reported to be symptomatic).
In both cases we have benefits that are below the marginally clinically significant threshold over 18 months of therapy.
I don’t think we can write this drug off entirely with just a press release and 18 months of therapy, but this hardly sounds like a “breakthrough”.
You pointed out the difficulty in assessing responses to Alzheimer's treatment by use of MRI and cognitive testing. A possible solution was discussed using an objective test using saccadic eye movement in the 2022 June edition of Alzheimer's Disease.
"Of course, my skepticism could end up being misplaced."
Certainly, Doctor, the possibility exists. Given the preliminary data and the lucidity of your exposition, however, such an outcome seems plausible as a hypothesis, but with a highly constrained confidence interval.
I’m definitely in agreement that this trial is barely better than a flop, but biogen will do everything they can to gain approval and sell billions of dollars worth to desperate families.
Consider that the 0.45 point higher score (on an 18 point scale) is barely better than the 0.35 point difference seen for aduhelm. Still around 20% of participants had brain edema on imaging (although less were reported to be symptomatic).
In both cases we have benefits that are below the marginally clinically significant threshold over 18 months of therapy.
I don’t think we can write this drug off entirely with just a press release and 18 months of therapy, but this hardly sounds like a “breakthrough”.
Casava Science Phase III trials, promising with no side effects
Forget the price of an MRI, try getting them to lay still.
Dr. Hollander:
You pointed out the difficulty in assessing responses to Alzheimer's treatment by use of MRI and cognitive testing. A possible solution was discussed using an objective test using saccadic eye movement in the 2022 June edition of Alzheimer's Disease.
"Of course, my skepticism could end up being misplaced."
Certainly, Doctor, the possibility exists. Given the preliminary data and the lucidity of your exposition, however, such an outcome seems plausible as a hypothesis, but with a highly constrained confidence interval.