26 RESULTS
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COMMENT This represents another major advance in the field of AD research. In the target population—people with intermediate amounts of tau based on tau PET at baseline—a slowing of 36 percent based on the CDR-SB or 35 percent based on the iADRS was demonstrated,
COMMENT Since the A4 study was first started in 2013, it represents a ground-breaking public-private partnership that first tested the hypothesis that individuals with evidence of amyloid plaques, but without cognitive impairment, might benefit from disease-modif
COMMENT The recent publication by Petersen et. al., of which I am a co-author, represents an advance in the field regarding how we might interpret clinical trial results in patients with early AD (MCI and mild dementia due to AD). Some previous publications have
COMMENT From a practical standpoint, the lack of accelerated approval should have little effect on the donanemab program. Because CMS does not reimburse for monoclonal antibodies for AD that receive accelerated approval (except through a CED study), significant c
COMMENT The presentation of the Clarity AD trial results at CTAD this year represents a seminal change in the field of AD research. The positive results for clinical outcomes in the study are most important, but the history and development of the program are equa
COMMENT This is a groundbreaking result with regard to AD research and treatment. Since donepezil was first approved by FDA in 1996, there has likely been no new information as impactful as the press release from Eisai on September 27, 2022, stating that the Phas
COMMENT Thank you for citing our recent publication about the role of astrocytes in Huntington disease (HD). We are particularly pleased to share this with the AD community as we believe astrocyte reactivity is a pathogenic mechanism that can contribute to diseas
COMMENT comments in this article in Alzforum, other laboratories could not replicate the results from Dr. Lesné,
COMMENT The results from this study of crenezumab in patients with preclinical autosomal-dominant AD are certainly a disappointment for the field. GNA, Banner, Roche, and the NIA are to be congratulated for performing such a challenging trial. Nevertheless, there
COMMENT important consideration that came from the open comment period and the CMS decision is how aducanumab should
COMMENT In some respects, the request for public comments by CMS regarding its proposed decision on
COMMENT The major question for the CMS regarded reimbursement for aducanumab; however, the regulatory pathway and questions surrounding efficacy are clearly linked to that consideration. The clinical review of the aducanumab BLA from the Office of Neuroscience at
COMMENT There has been some confusion and controversy in the field regarding the accelerated (not full) approval of aducanumab. The FDA has used the accelerated approval regulatory pathway since 1992, though primarily for HIV and cancer treatments. It allows a dr
COMMENT A historic moment was achieved with the accelerated approval by FDA of aducanumab for the treatment of Alzheimer’s disease. This decision will not be made in the absence of controversy, given the results from two identically designed pivotal trials for ad
COMMENT The FDA advisory committee meeting held on November 6, 2020, yielded an overall negative view by the committee members of the aducanumab submission. The meeting itself, however, was not able to discuss adequately the most pertinent issues given the proces
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