Recent research raises concerns about the real-world effectiveness of Leqembi, a new drug approved by the US Food and Drug Administration to slow the development of Alzheimer’s disease.
Published in the Annals of Family Medicine, this study questions the drug’s practical benefits against its big costs and potential side effects.
Leqembi, which became available for coverage under Medicare, was initially seen as a hopeful treatment for millions of Americans in the early stages of Alzheimer’s.
However, the study paints a different picture. The research did a systematic review of 19 publications with over 23,000 participants, including an analysis of eight monoclonal antibodies, among which Leqembi was a key focus.
Mark Ebell, a physician and professor at the University of Georgia, emphasized the study’s focus on outcomes that matter to patients and caregivers.
Their findings showed that the improvements in cognitive and functional abilities in treated patients were so minor that they were unlikely to be noticeable in everyday life.
The study measured the drug’s impact on memory and daily life skills, like dressing and feeding oneself. While some improvements in cognitive function were noted, these did not bring clinical enhancements in memory or behaviors.
The potential side effects of Leqembi, including brain swelling and brain bleeds, combined with its high cost and time demands, raise concerns about the overall benefit of the drug.
These factors must be carefully considered when evaluating its suitability for patients.
The team points out that while there is a promise of breakthrough treatment, it’s crucial for doctors and patients to understand the limited benefits in relation to the potential risks. Making an informed decision requires balancing the potential benefit with any possible harms.
The study urges caution in the widespread adoption of Leqembi, given its minimal impact and significant risks.
This is particularly important in the context of a disease like Alzheimer’s, where treatment decisions can profoundly affect the quality of life of patients and their families.
Their work underscores the importance of not only considering statistical improvements in clinical trials but also focusing on meaningful, noticeable changes in the daily lives of patients and their caregivers.
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The research findings can be found in the Annals of Family Medicine.
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