22 RESULTS
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COMMENT The FDA Advisory Committee’s unanimous recommendation that donanemab receive full approval represents an important step forward in the treatment of Alzheimer’s disease. ARIA, the principal adverse event, is usually transient, asymptomatic, and manageable
COMMENT I welcome the CMS decision to end the CED for PET amyloid imaging and the removal of the limit on amyloid PET to a single lifetime scan. Assuming that local MACs follow suit, this should provide wider access for amyloid PET in clinical practice, opening t
COMMENT The Trailblazer results represent a major advance in the treatment of AD. The study included important innovations such as use of amyloid and tau PET to determine the disease stage and implementing stopping rules based on amyloid-lowering with PET. It rem
COMMENT I want to thank the amazing contributions and dedication of the study participants, some for more than eight years, to the A4 study. We had a great sense of excitement when we provided the first infusion to launch the A4 study at Butler Hospital in June o
COMMENT These are disappointing top-line results from a well-run trial. We need to evaluate the safety and efficacy for each compound in this class and learn as much as we can from each study. There appears to be a small clinical benefit with gantenerumab that di
COMMENT We are disappointed with the final CMS NCD, which essentially denies access to treatment with aducanumab and future amyloid-lowering treatments receiving accelerated approval. Aducanumab will only be available to patients who can afford to self-pay and th
COMMENT Essentially, CMS needs to abandon the randomized controlled trial requirement and find a more balanced approach that provides access, generates real-world data on safety and efficacy, and stimulates investment and innovation. That can be achieved through
COMMENT The intent of the FDA accelerated approval for aducanumab, and potentially for other anti-amyloid antibodies, is to provide eligible patients access to medication that may benefit them while mandating confirmatory research and to stimulate investment and
COMMENT Early termination of studies 301 and 302 and a dose increase midway through the trial led to an incomplete dataset and clearly complicate the interpretation of the results. However, the totality of the data provides evidence of dose-related lowering of am
COMMENT We were disappointed that the DIAN-TU trial did not meet its primary cognitive endpoint. The small sample that combined preclinical and symptomatic patients, variable range in expected time to disease onset, and late escalation to the high dose may have c
COMMENT We have postponed observational study visits but are continuing study infusions for now. Participant attendance is good, but we have seen a mild increase in cancellations because some retirement communities are encouraging residents to stay home, plus gen
COMMENT DIAN-TU is a visionary study comprising valiant volunteers. The negative primary outcome is disappointing. Additional analyses are underway to learn as much as we can about Alzheimer’s disease from this trial. A platform has been created and is moving for
COMMENT Approval in China for a new treatment for Alzheimer’s disease is encouraging. We await publication of the study that led to approval. From the data presented at CTAD, cholinesterase inhibitors were not allowed and the drug worked best for those with a Min
COMMENT It was very disappointing to learn that Biogen plans to close the ENGAGE trial because of lack of efficacy on the interim analysis. We had been eagerly looking forward to the results next year and this came out of the blue. This antibody did not work for
COMMENT I am cautiously optimistic. The reported level of amyloid lowering was surprisingly high, more than 80 percent amyloid negative by visual read. This is interesting in that the antibody has higher affinity for protofibrils than plaques. The cognitive resul
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