Exclusive: As enthusiasm mounts for a new experimental antibody that appears to slow cognitive decline in some Alzheimers patients, a third death linked to the drug during its clinical testing may amplify concerns about its safety.
Eisai, which attributed the prior fatalities and brain injuries to factors unrelated to lecanemab, declined to comment on the Florida woman’s death, citing patient privacy concerns. “All serious events, including fatalities, are reported to Eisai and considered in our evaluation of the study,” a company spokesperson said in a written statement to.
Lecanemab is one of several experimental Alzheimer’s drugs that target beta amyloid, the protein that builds up in the brains of people with the disease. Many in the field believe it is responsible for the brain cell death that robs people of memories and ultimately kills them, although deposits of the protein are also found in brains of healthy people.
Whether the woman received infusions of the antibody or a placebo during the core 18-month trial is unclear. But she did get the drug over 6 weeks in the extension phase—in which any participant can opt for treatment. Before the extension trial started, a brain scan revealed signs of a few microhemorrhages, but they were not serious enough to rule her out of the trial.and authorized their review by others.
The hospital records show the clinical trial site investigator, contacted after the woman was hospitalized, suspected ARIA and urged treatment with steroids—which the physicians tried without significant benefit. She began to suffer from multiorgan failure and pneumonia, and died 5 days after being admitted.
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