30 RESULTS
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COMMENT Protocol amendments during the trials increased the dose for APOE4 carriers from 6 to 10 mg/kg, allowed restarting aducanumab in people with ARIA who more likely than not were APOE4 carriers, and increased the size of each trial to 1,605. It’s important ...
COMMENT The conditional marketing approval by China’s FDA, the NMPA, for GV-971 also limited its price to twice that of donepezil. If donepezil is as cheap in China as it is at Costco (i.e., $30.30 per year with a GoodRx coupon), then $60.60 is a steal for this ...
COMMENT The outcomes of the aducanumab and crenezumab Phase 3 trials are disappointing but are as expected. Neither of the antibodies showed clinical efficacy evidence in their earlier phase trials. The previous, and regularly repeated, claims of efficacy from ...
COMMENT As a note of caution: A press announcement is not a scientific report. There are no protocol, methods, and data presented from which inferences can be made. It’s carefully written for investors betting on prices, to fulfill compliance obligations, and ...
COMMENT The 2018 edition of the FDA draft guidance better conceptualizes the 2013 draft guidelines. For example, FDA now refers to three stages of “early Alzheimer’s disease” rather than “early stage Alzheimer disease.” They operationalize diagnostic criteria ...
COMMENT Consider that what we are doing in Alzheimer-related drug development is trying to develop drugs that are expected to have very small statistical and clinical effects. The Phase 3 trials are based on the outcomes from negative Phase 2 trials. The very few ...
COMMENT A calculated perspective on solanezumab’s outcomes Much discussion about Expedition 3 treats the p values as though they are measures of magnitudes of effects. For example, since the p values range from.004 to.14 and four of the six outcomes presented are ...
COMMENT This straightforward, “rite-of-passage,” multiple ascending dose, safety and tolerability study demonstrated that an aducanumab dose range from 3 to 10 mg/kg reduced amyloid fibrils and was safe enough for use in the ongoing Phase 3 pivotal efficacy ...
COMMENT The accumulating evidence for decreases in the age-specific incidence of Alzheimer disease or dementia, over fairly short periods of five to 10 years, encourages speculating that this may be due to environmental and public health improvements over the ...
COMMENT Three considerations in interpreting this trial are: the use of the term "agitation" and vague inclusion criteria; the drug combination tested along with the concomitant medications used by participants; and the magnitudes of the clinical ...
COMMENT The big picture here is that Prana’s only prior Phase 2 trial with PBT2 — completed in 2007 with 78 mild AD patients treated for 12 weeks — showed lower CSF Aβ42 and nominally significant effects on verbal fluency and working memory. A reasonable ...
COMMENT In this small Phase 2 trial of only 109 patients the sponsor's safety objectives were met, and there appears to be no regulatory barrier to going forward to Phase 3 and assessing PBT2 for efficacy. The trial wasn't intended as an efficacy trial ...
COMMENT The topline results of the Phase 3, bapineuzumab trial 302 are disappointing but not surprising. That is mainly because the prior Phase 2, 201 trial was a multiple ascending dose trial, not planned as an efficacy trial, and didn’t show reliable efficacy ...
COMMENT Very nice studies of how a classic small molecule with action at numerous receptors could be therapeutic for AD. lschneid 0 ...
COMMENT Semagacestat continues the streak of late-phase trial failures. All failed for lack of efficacy, but as enzyme inhibitors and antibodies are advanced, serious toxicity in the trials may become more frequent as well. Sequential failures discovered late in ...
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