An article in the journal “Neurology” has caught the attention of the medical and scientific community. It warns about a possible shrinkage of the brain in patients receiving lecanemab and other similar drugs for the treatment of Alzheimer’s disease in clinical trials.
Lecanemab received accelerated approval in the US in January even though scientists have documented this loss of brain volume in clinical trial participants for years. It is a monoclonal antibody that is given as an intravenous infusion every two weeks with the goal of clearing amyloid beta plaques that build up in the brain, a toxic protein linked to Alzheimer’s disease.
Studies submitted for approval suggest the new drug holds more promise than available alternatives. So much so that the prestigious magazine ‘Nature’ included this treatment among the great scientific advances expected for this year. The test was the latest clinical trial where it was tested with 1,795 people with early-stage Alzheimer’s. This research showed that lecanemab slowed cognitive decline by 27% compared to placebo. It was also associated with two deaths in people treated with this innovative drug.
This new scientific review is the first to analyze data from numerous studies with the drug. He also links brain shrinkage to a better-known side effect of medications, brain swelling, which often occurs without symptoms.
The article in “Neurology” warns of a possible reduction of the brain in patients receiving lecanemab and other similar drugs in clinical trials. The paper’s authors note that this shrinking of the brain could have unknown and potentially dangerous consequences.
The analysis, which found that trial participants taking these Alzheimer’s drugs often developed more brain shrinkage than when taking a placebo, alarmed Scott Ayton, of the Florey Institute for Neuroscience and Mental Health in Melbourne, Australia, who led the study. job. “We are talking about the possibility of brain damage” from the treatment, he says. «I find it very peculiar that these data, which are very important, have been completely ignored by the fieldAyton adds.
While it’s true that Alzheimer’s disease itself causes the brain to shrink as the disease progresses, the researchers found that both types of drugs generally caused participants in clinical trials to lose more brain volume than was seen in clinical trials. Alzheimer’s patients who received a placebo. Lecanemab and another antibody, donanemab, made by Eli Lilly and Company and currently in late-stage trials, both “accelerate total brain volume loss,” Ayton writes in his article.
The prestigious magazine ‘Nature’ included this treatment among the great scientific advances expected by 2023
According to the study, the “Science” report, people who participated in two large trials of lecanemab with the highest dose of the drug, which is the one approved by the FDA, registered, on average, a 28% greater loss of brain volume in relative to placebo after approximately 18 months.
In fact, the FDA officials who approved the lecanemab application noted the changes in brain volume. However, like the company, they were not overly concerned.
From the manufacturing company itself, Eisai, it is suggested that there are also benign theories about brain contraction. The company said in a statement that although participants in its pivotal trial experienced “greater cortical volume loss with lecanemab compared with placebo”those reductions may be due to the antibodies clearing the amyloid beta protein from the brain and reducing inflammation.
Although many Alzheimer’s experts agreed that the benefit on cognitive decline was modest, others, especially associations of patients and their families, welcomed the results because it has been so difficult to find drugs that stop the devastating loss of cognition.
negative or positive
However, the study authors in “Neurology” acknowledge that more studies are needed to determine whether brain shrinkage is a common side effect of drugs that reduce beta-amyloid protein deposits. They also suggest that it is necessary to determine if the reduction of the brain has any negative effect on the cognitive function and the performance of the patients.
Despite the concerns raised in the article, it is important to note that the mechanism behind brain shrinkage and its possible impact on patients. Shrinking the brain may not have negative effects and may even be beneficial in some cases.