29 RESULTS
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COMMENT The advisory committee voted 11 to 0 on both questions in favor of the approval of donanemab. The committee recognized, correctly I think, that the data supported a modestly favorable benefit to risk ratio for donanemab. The committee acknowledged uncerta
COMMENT The carefully presented observations by Banerjee et al. show that it is likely that Alzheimer pathology can be transmitted iatrogenically. From a clinical perspective, I hope that the lay press doesn’t over-react to this finding because the practical risk
COMMENT Amyloid PET imaging offers advantages over CSF analysis for establishing the presence of elevated brain amyloid, and this has implications for routine diagnosis but especially for therapeutics. As we enter the new therapeutic era with lecanemab, the CMS d
COMMENT The amyloid-negative (A-)/flortaucipir (FTP) medial temporal lobe (MTL)-positive (FTP-MTL+) group has not previously received attention, and the current report helped to fill that gap nicely. This is a well-done and clearly written piece that makes the po
COMMENT The donanemab Phase 3 trial is a major accomplishment on many levels: its unequivocal success in demonstrating clinical benefit, the fact that Lilly was able to conduct and complete a very large Phase 3 trial within two years of reporting the Phase 2 stor
COMMENT Lecanemab achieved a statistically significant result on its primary outcome, its secondary outcomes, and many of the biomarkers. To me, this result appropriately deserves a discussion of clinical meaningfulness. The group-wise 27 percent reduction in dec
COMMENT This decision came as a surprise to me. However, I was not a fan of accelerated approval ever. A regular approval for donanemab was ultimately what was important, if of course the Phase 3 trial showed clinical benefits. knopman 0
COMMENT The NEJM article and the oral presentation at CTAD on the results of the CLARITY trial with lecanemab 10 mg/kg Q2W were encouraging. The primary outcome, all of the secondary outcomes and the fluid and imaging biomarkers all were consistent with a modest
COMMENT The positive results announced yesterday by Eisai are heartening. Based on the information in their press release, the Phase 3 trial of lecanemab achieved its primary outcome and showed benefits on secondary outcomes as well. Lecanemab had a low rate of A
COMMENT That apparently non-specific multi-morbidities are associated with dementia risk is not a novel observation, but the large sample size of the UK Biobank enabled a detailed look at this enigmatic but very important observation. Apart from the fact that the
COMMENT Two groups, one from Eisai and the other from Roche, both with about-to-read-out phase 3 trial programs, reported at AAIC on the modeling of long-term benefits of anti-amyloid monoclonal antibody (AAMA) therapy. The Eisai model was based on data from thei
COMMENT The crenezumab trial in the Colombian dominantly inherited AD cohort is disappointing, but not altogether unpredicted based on earlier failures of crenezumab in sporadic AD, and based on the inability of crenezumab to clear brain amyloid to any extent (Sa
COMMENT The CMS Decision Memo issued on April 11 is a complex document. There are two separate coverage with evidence development (CED) determinations. For the first, the requirement for participation in a randomized controlled trial to cover an anti-amyloid mono
COMMENT The large number of comments to CMS is a testament to the intensity of the controversy surrounding aducanumab. Despite attempts by some to politicize this debate, the conversation about evidence has not changed. The facts are the same now as they were pri
COMMENT I was saddened to learn of John’s passing, because he was a member with outsized influence of the extended family of dementia neuroscientists. John was always gracious and respectful of all. His exuberance for science and his thoughtfulness lit up the roo
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