Mattke S, Yue S, Becker A, Liu Y. Demographic and clinical characteristics of initial patients receiving amyloid-targeting treatments in the United States after regulatory approval. Alzheimers Dement. 2025 Mar;21(3):e70054. PubMed.
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Columbia University
Our center began offering donanemab earlier this year.
Patient discussions around decisions of prescribing lecanemab versus donanemab principally reflect the data and findings which were already known, as published in the randomized, controlled, clinical trial (RCT), and, when available, in the open-label extension studies. The Appropriate Use Recommendations for lecanemab provide helpful context and are generally similar to the RCT. I anticipate continuing to use the primary study data along with the AUR for donanemab (or others in the future) in a similar manner.
In considering a path toward increasing access and availability for the broader field of neurologists, I would think that an AUR of sorts for lecanemab versus donanemab would be most helpful, but I’m not aware such a document exists.
To date, factors leading to decisions on which drug to use include clinical experience, drug availability, ARIA risk—including that relative to APOE genotype—and logistics, including timing/schedule. These all weigh into patient-centered, risk-benefit discussions.
The recent FDA decision around post-18-month lecanemab dose adjustments from twice to once monthly has been a recent factor in my patient discussions, primarily around logistics. Should any of the medications become available in other forms, I anticipate that will factor into elements of logistics informing choice. A missing piece remains long-term outcome data. While some models have been published, once better long-term outcome data are available, I anticipate that information will help better frame treatment decisions.
View all comments by James NobleUK Dementia Research Institute@UCL and VIB@KuLeuven
A similar situation occurred with lecanemab, which was rejected by the EMA on the grounds that its benefits did not sufficiently outweigh the risks of potentially fatal ARIA events. In the case of donanemab, the decision appears to have been influenced by data suggesting that the risk of ARIA-related bleeding may also be elevated in individuals who do not carry the ApoE4 allele, making targeted exclusion of high-risk patients more difficult.
At present, it remains unclear whether there is a clinically meaningful difference in the safety profiles of lecanemab and donanemab, and this distinction requires urgent clarification. It is concerning that the EMA continues to apply such restrictive criteria to the approval of innovative therapies for Alzheimer’s disease.
View all comments by Bart De StrooperMake a Comment
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