Sydney (Australia) (EFE)
Lecanemab, developed by the Japanese pharmaceutical Eisai and the American Biogen, was experimentally approved in January by accelerated procedure in the United States, after trials in which it reduced cognitive impairment in patients by 27 percent.
However, the “Neurology” study, led by scientist Scott Ayton of the Florey Institute of Neoscience and Mental Health in Australia and published on March 27, found that patients taking lecanemab suffered a 28 percent brain shrinkage. greater than those who were treated with a placebo.
The authors of the article call for further investigation to confirm whether these changes may have harmful long-term consequences for patients.
Ayton, along with colleagues Francesca Alves and Pawel Kallinowski, conducted a meta-analysis of 31 clinical studies on drugs against Alzheimer’s, a neurodegenerative disease that causes cognitive impairment in patients.
Brain shrinkage in patients treated with lecanemab and donanemab
The shrinkage of the brain occurred in patients treated with lecanemab and donanemab, another similar drug, both used to reduce the protein beta amyloid, linked to Alzheimer’s.
“It is possible that accelerated brain atrophy is caused by other factors, but when considering the possibility of brain damage, we should be cautious in our interpretations and accumulate more data,” Ayton said on Twitter.
“We recommend that doctors alert patients to the risk of brain atrophy, that brain atrophy be actively monitored in clinical trials (including long-term follow-up), and that pharmaceutical companies running the trials publish more information about changes in brain volume,” he added.
According to the magazine “Science,” Eisai indicated that the loss of brain volume could be due to the elimination of the amyloid beta protein and the reduction of inflammation, while he continues with clinical trials.
The US Food and Drug Administration (FDA) is pending phase four clinical trials for lecanemab in order to grant it permanent authorization, while authorities in the European Union, Japan and China are also considering approval of the drug. drug.