Lecanemab it’s a medication to treat Alzheimer’s that it has shown efficacy in the studies in which it has been tested and that it offers great hope for combating this neurodegenerative disease whose incidence continues to increase –it is estimated that there are 50 million affected worldwide– because recently a clinical trial in Phase III showed that it slowed the progression of cognitive decline in patients in the early stages of this dementia by 27%, compared to placebo.
This trial was carried out in 1,795 patients between the ages of 50 and 90 with early Alzheimer’s disease and the drug was able to reduce markers of amyloid beta protein and cognitive losses associated with the disease. However, the drug is still in the experimental phase and have been observed unwanted side effects, such as bleeding that could be related to the death of two people. Now, a new study has found that lecanemab treatment also causes a accelerated reduction in brain volume.
Specifically, the analysis shows that patients who take it have experienced a decrease in the size of his brain by 28% greater, than those taking placebo. Donanemab, another experimental Alzheimer’s drug, has been associated with similar effects. The curious thing is that Alzheimer’s disease is characterized by destroying neurons and gradually shrinking the brain of patients, and for this reason it is so surprising that a drug designed to stop its progression causes a shrinkage of the brain greater than the pathology itself.
To carry out the new research on the effects of lecanemab, the results of 31 clinical trials of drugs designed to remove beta amyloid protein, one of the causes of Alzheimer’s. “Our results are worrying,” warned Scott Ayton, a neurologist at the University of Melbourne (Australia) and lead author of the paper, which has been published in Neurology. “We do not know what consequences the observed reduction in brain volume may have, so we call for more studies.”
Loss of brain volume and inflammation of the brain
“The pharmaceutical companies that funded these clinical trials have a wealth of data that can shed light on this problem of atrofia cerebral, but these data have barely been analyzed and the companies have not published them,” said Ayton, who was an adviser to Eisai, the Japanese company that developed lecanemab together with the American Biogen. This expert claims that he alerted the company to these results and asked them for detailed data on brain volume, but they did not provide them.
Lecanemab could obtain marketing approval this year in the United States and the European Union. In fact, the FDA approved it at the beginning of the year by the accelerated procedure, although this approval is linked to the completion of phase four clinical trials that, if they finally show that the drug is effective, would allow the agency to grant traditional approval to the drug. compound.
Neurologists Frederik Barkhof and David Knopman have highlighted the “uncertainty” about the effects of the “enigmatic” loss of brain volume in an editorial accompanying Ayton’s article. And they affirm that, although it is possible that it does not have an impact on the health of the patients, they rule out that the shrinkage of the brain is due solely to the disappearance of amyloid protein plaquesas an Eisai spokesperson has suggested in statements to the daily The country.
The findings of the new study also reveal that brain ventricles of patients swell and that this is related to marks of inflammation in the brain. “It is worrisome that a marker of brain health such as brain volume and the ventricles go in the opposite direction” from what would be expected with a therapeutic intervention, write the neurologists, who point out that to see if the desired results are obtained or not, the only solution is to continue observing the patients who took these drugs. .