The most promising Alzheimer’s drug shrinks the brain

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Lecanemab, the promising Alzheimer’s drug that slows cognitive decline in patients with early-stage disease, appears to reduce brain volume. Experts are investigating the consequences of this effect.

The most promising Alzheimer’s drug shrinks the brain

Lecanemab is a drug to treat Alzheimer’s that has shown efficacy in the studies in which it has been tested and that constitutes great hope for combating this neurodegenerative disease whose incidence continues to increase – an estimated 50 million people are affected worldwide. world– because a phase III clinical trial recently 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 unwanted side effects have been observed, such as bleeding that could be related to the death of two people. Now, a new study has found that lecanemab treatment also causes an accelerated reduction in brain volume.

Specifically, the analysis shows that patients who take it have experienced a 28% greater decrease in the size of their brains than those who take 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 eliminate the amyloid beta protein, one of the causes of Alzheimer’s, have been reviewed. “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 brain atrophy, but that data has barely been analyzed and the companies have not published it,” said Ayton, who was a consultant to Eisai. , the Japanese company that has 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 the amyloid protein plaques, as an Eisai spokesperson has suggested in statements to the newspaper El Country.

The findings of the new study also reveal that patients’ brain ventricles swell, and that this is linked to marks of inflammation in the brain. “It is worrisome that a marker of brain health such as the volume of the brain and ventricles go in the opposite direction” from what would be expected with a therapeutic intervention, write the neurologists, who point out that to verify if the desired results are obtained or The only solution is not to continue observing the patients who took these drugs.

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