47 RESULTS
COMMENT This may have been the fourth randomized Phase 3 trial of a form of methylene blue in various doses by this company. None was statistically significant compared to their contemporaneous controls. The trials used a small dose of HMTM or similar as the cont
COMMENT Cancelling Aduhelm is an uncontroversial decision. Aducanemab was the vehicle on which FDA established its approval standards for amyloid antibodies: (1) plaque lowering buys accelerated approval, and (2) a touch of statistical significance on a composite
COMMENT The donanemab Phase 3 outcomes—according to Lilly’s press release—are remarkably like its Phase 2 trial outcomes and the Clarity-AD lecanemab Phase 3 trial. The iADRS mean differences were approximately 3.26 in the targeted intermediate tau group and 2.88
COMMENT journal Science. As I mentioned previously in Alzforum (comment on No Easy Answers on Clinical
COMMENT The title of the Alzheimer’s Association’s presser sums it up: “EXPERTS REDEFINE 'CLINICAL MEANINGFULNESS' IN ALZHEIMER’S.” This is straight from the silver linings playbook. If you don’t like an outcome, then change the game plan, make up a rul
COMMENT I don’t think I see what the authors claim about antipsychotics for dementia. The U.S. data is different from the ex-U.S. The two U.S. databases show decreases in dementia diagnoses in 2020, especially during the spring, followed by compensatory increases
COMMENT might prove interesting. There are several ways to interpret Roche’s comments that gantenerumab didn’t
COMMENT Given that this is a press release, not a scientific report, and taking it at face value—often a chancy thing to do—the primary outcome is statistically significant at P < 0.0001. On its face, other things being equal and assuming a low risk of bias, t
COMMENT Of course, clinical and biomarker effects could grow. If your model is projecting the slope of an existing difference it will grow over time, assuming that the conditions remain constant. That is, if the benefits of the drug in reducing plaque are durable
COMMENT This negative TAURIEL semorinemab trial in prodromal Alzheimer disease (MMSE 30 to 20) received far more notice than its sibling LAURIET trial (NCT03828747) in mild to moderate AD dementia (MMSE 21 to 16). Yet, in LAURIET there was a highly significant ef
COMMENT As of February 17, there were 9,956 comments posted that could be arranged in alphabetical or
COMMENT The basis for aducanumab’s approval was an unvalidated surrogate biomarker and not FDA’s standard low bar of substantial evidence of effectiveness in clinical trials. The FDA does not view clinical benefit as necessary for marketing approval on the accele
COMMENT Aduhelm was dropped on the public having failed the minimal FDA standard for regular approval, i.e., substantial evidence of effectiveness, as clearly demonstrated by the FDA’s independent statisticians. Seemingly as a work-around, it was given accelerate
COMMENT New Kid in Town – “everybody’s talking, everybody’s walking” In a brief, 400-word letter to the New England Journal of Medicine last week, the FDA clearly defined its idea of substantial evidence for effectiveness in Alzheimer’s and implicitly, criteria f
COMMENT This is face-saving by the FDA, who were obviously closely involved and strong advocates for aducanumab’s “substantial” effectiveness. Efficacy was not established as the post hoc analyses, at best, showed a trivial difference. The FDA reached back to its
