34 RESULTS
COMMENT The Phase 3 donanemab results are great news for the field, still further confirmation that disease progression can be slowed by robust removal of fibrillar amyloid from brain. We all eagerly await full presentation of the data from this innovative study
COMMENT I was pleased that the presentation on lecanemab at CTAD was received with almost uniform excitement and enthusiasm. With intervention at the early AD stage, we can slow AD progression by 27 percent, a clearly meaningful benefit. Functional decline slows
COMMENT Plasma p-tau217 measured by immunoassay or mass spectrometry has emerged as a tremendously valuable biomarker for AD pathology. Alone, or in combination with Aβ42/20 ratio by mass spec, plasma p-tau217 is an accurate predictor of amyloid PET and tau PET r
COMMENT This is a definitively positive, pivotal trial, hitting the primary and each key secondary cognitive/clinical endpoint. The results support full approval of lecanemab in early AD, and provide support for the amyloid therapeutic hypothesis (and for the FDA
COMMENT This is essentially a non-coverage decision. The FDA granted accelerated approval to aducanumab based on evidence from multiple trials of aducanumab (PRIME and EMERGE), lecanemab, and donanemab that substantial amyloid reduction in brain is associated wit
COMMENT I am very excited that with the launch of Skyline, a third promising anti-amyloid immunotherapeutic is being tested in the presymptomatic (preclinical) sporadic AD population. Building on the experience of the A4 trial of solanezumab and the AHEAD platfor
COMMENT I am very disappointed by this decision. It is essentially denying coverage to aducanumab and other drugs in the class. I agree with the FDA decision that dramatic reduction of brain amyloid, as seen with aducanumab treatment, is reasonably likely to resu
COMMENT The AAIC presentations on donanemab and lecanemab provide further support to the idea that removal of brain amyloid results in slowing of cognitive/clinical decline; this is important support for the use of aducanumab as well. Much remains to be learned,
COMMENT The FDA has granted accelerated approval to aducanumab, based on evidence across three trials that the drug reduces amyloid in brain, along with the reasonable likelihood that amyloid reduction will result in clinical benefit. A major issue with this deci
COMMENT The plasma biomarkers of AD pathology that have arrived on the scene in recent years are truly impressive, and p-tau217 is among the best. Elevated p-tau217 or low Aβ42/40 ratio (by mass spec) places an individual on the AD spectrum. Biomarkers such as hi
COMMENT The Phase 2 donanemab results are exciting and important. This innovative trial of a highly potent amyloid-normalizing antibody met its primary cognitive/functional endpoint. As with other such antibodies, a significant number of participants developed AR
COMMENT Our primary manuscript from the EARLY trial of the BACE inhibitor atabecestat is in press. In the paper, we’ve addressed the interesting findings noted in the papers by Merck and Lilly. The EARLY trial was truncated due to hepatic safety concerns but in t
COMMENT The FDA advisory committee meeting and its aftermath have been discouraging. The submitted data is highly challenging, with two interrupted Phase 3 trials yielding discordant results. But the tenor of the meeting and subsequent discussion have generally b
COMMENT This valuable paper from Eric Reiman and colleagues provides a strong rationale for targeting APOE in AD therapeutic research. APOE alleles are the most important risk factors and protective factors in sporadic AD; understanding the mechanisms of these ef
COMMENT I am a member of the Aducanumab Steering Committee, so I continue to play an advisory role to Biogen. Q: Based on the data you s aw, does this new analysis look appropriate? A: Yes. Q: When ADCS did an independent analysis of Lilly's solanezumab data
