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A second patient died of a brain hemorrhage — an anti-amyloid side effect — in studies of Eisai’s lecanemab treatment for Alzheimer’s disease.
A 65-year-old woman with early Alzheimer’s disease suffered a fatal brain hemorrhage while receiving Eisai’s experimental Alzheimer’s antibody treatment lecanemab. This is the second death related to the Phase 3 trial, raising additional safety concerns.
In late September, Eisai and Biogen announced that their experimental anti-amyloid drug lekanemab successfully slowed cognitive decline in Alzheimer’s patients, according to early data from Clarity AD, a Phase 3 trial of the drug. In late October, an 80-year-old participant in the lecanemab trial was reported to have died, also from a cerebral hemorrhage.
According to an unpublished case report obtained by Science magazine, in the case of this second participant’s death, the woman received lecanemab infusions during the trial. She suffered a stroke and developed brain swelling and bleeding known as amyloid-related imaging abnormalities (ARIA).
ARIA is a known side effect of Alzheimer’s amyloid drugs and has been seen in patients taking previous treatment from the Alzheimer’s amyloid drug maker, Aduhelm. In Aduhelm, ARIA was often mild and asymptomatic and occurred in about 40 percent of participants.
The risk of a combination of blood thinners and antiamyloids
In response to the woman’s stroke, emergency room staff administered tissue plasminogen activator (tPA) to treat blood clots, a common stroke intervention. This step appears to have stimulated bleeding in the outer layer of her brain, according to the case report described by Science.
in of science interviews with her husband after her death and in her case report notes the event is extremely dramatic.
“As soon as they put it in her, it was like her body was on fire,” her husband said Science of tPA administration. “She was screaming and it took about eight people to restrain her. It was terrible. Everyone runs and [asking] ‘What the hell is going on?'”
She had seizures, was put on a ventilator and died a few days later.
The Eisai ClarityAD trial consent form, which is 30 pages long, contains a warning about blood thinners and their association with an increased risk of brain hemorrhages, according to Science.
Alzheimer’s trial deaths raise questions about drug safety
After the first death, it was unclear whether the hemorrhage was caused by the drug experience, and the link remains unproven. Still, this second death among trial participants, consistent with both the first death and the risks of anti-amyloids, heightens questions about the safety of lecanemab and about how widely it should be prescribed if it does secure FDA approval. .
This summer, it received “breakthrough status” from the FDA, guaranteeing it priority review by regulators. At the time, the FDA indicated it intended to announce its decision by January 6, 2023.
Neuropathologist Rudolph Castellani of Northwestern University Medical Center in Chicago, who studies Alzheimer’s disease, performed the autopsy at the request of the husband of the woman who died during the trial.
Castellani shared his personal opinion on the case with science: “There is no doubt in my mind that this is a treatment-induced illness and death,” he said. “If the patient had not been on lecanemab, she would be alive today.”
Eisai has yet to comment directly on the case, but said Science in a statement: “It can be difficult to determine what contributed to a patient’s death, especially when they are elderly, have multiple medical problems, and may have recently received concomitant treatment or intervention for an acute condition.”
The ClarityAD studies will continue to gather data on the drug’s efficacy in reducing cognitive decline in people with early-stage Alzheimer’s disease.
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