An experimental treatment for Alzheimer’s disease may pose a risk of life-threatening brain bleeding for some patients, a research report released this week suggests. paper, has been published A 65-year-old woman died of bleeding, the journal Science reported on Monday. taking a common blood thinner while taking an experimental drug. The incident is believed to be the second similar death linked to the treatment, which will be reviewed for approval by the Food and Drug Administration early next year.
The treatment is known as lecanemab and is jointly developed by the pharmaceutical companies Biogen and Eisai. It’s a lab-made antibody designed to go after amyloid beta, a protein thought to play a key role in Alzheimer’s disease. In people with Alzheimer’s disease, persistent, toxic clumps of amyloid, known as plaques, form throughout the brain and damage the brain over time. The drug first tries to break down amyloid deposits that haven’t turned into plaques, which in theory should stop or at least slow the progression of Alzheimer’s symptoms.
In early September, the companies announced the results of the latest Phase III trial of lecanemab. Compared with patients receiving placebo, patients receiving lecanemab had lower levels of amyloid and slower cognitive decline. The findings are the first to show that any anti-amyloid drug is clearly significant. if modest, the benefits of large-scale clinical trials. But even this apparent success has been tempered by these reports of fatal complications associated with the drug.
As part of its research, Science interviewed the woman’s family and doctors. They were also given access to an unpublished case report written by her doctors and asked outside experts to evaluate the findings.
The woman was part of the original 18-month trial of lecanemab, although she was part of the placebo group, according to the report. He was then given the option of starting lecanemab, which he agreed to do. A short time later, the woman suffered a stroke, prompting a trip to the emergency room at Northwestern University Medical Center in Chicago. He was then given blood thin tissue plasminogen activator (tPA), a common stroke treatment, to restore blocked blood flow. But soon after, his condition deteriorated rapidly as he developed a severe cerebral hemorrhage and was soon put on a ventilator. His family cut him off life support a few days later, with no hope of recovery.
“It was a one-two punch,” Northwestern neuropathologist and Alzheimer’s specialist Rudolph Castellani, who performed the woman’s autopsy at her husband’s request, told Science. “There is no doubt in my mind that this is treatment-related morbidity and mortality. “If the patient was not on lecanemab, he would be alive today.”
The report was released after a similar death informed A man in his 80s also developed a fatal brain hemorrhage while taking lecanemab and a blood thinner, according to STAT News in late October. In the adverse event report, Eisai acknowledged that the treatment played a role in the man’s death, but has since maintained that the death was unrelated and the incident is still under investigation.
Human trials of these anti-amyloid drugs have shown that they can increase the risk of brain bleeding in people who take them, but never to a life-threatening level. Experts interviewed by Science claim that the drug’s effect on amyloid deposits near blood vessels weakened them so much that administration of the blood thinner could have caused massive ruptures. If true, these reports could lead to a major reevaluation of the drug’s expected risks and benefits by the FDA, especially since many elderly patients at risk for Alzheimer’s must take blood thinners to treat or manage other health conditions, such as stroke. At the very least, it could lead to the advancement of clear warning labels attached to these drugs.
Most of the previous drugs in this class failed major clinical trials, including a candidate it recently failed the tests. Last year, the FDA approved the first such drug, Aduhelm, developed by Biogen and Eisai. But that was the decision broke immediately with controversy because the trial data supporting its approval was mixed at best, and the FDA went against the clear recommendations of an outside advisory committee in doing so. Aduhelm remains on the US market for now, but will not be routinely covered by Medicare until its manufacturers can provide additional compelling data for its effectiveness (in March, Eisai signed over any remaining liability to Biogen for Aduhelm).
As for Lecanemab, so is Eisai is expected to present more detailed results from its Phase III trial at an Alzheimer’s research conference later this week. FDA does is planned take a decision on approval by January next year.