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Second death linked to potential antibody treatment for Alzheimer's disease - Science

Second death linked to potential antibody treatment for Alzheimer's disease - Science

Nov 28, 2022 3 mins, 10 secs

The clinical trial death, described in an unpublished case report Science has obtained, is the second thought to be associated with the antibody called lecanemab.

Rudolph Castellani, a Northwestern neuropathologist who studies Alzheimer’s and conducted an autopsy at the request of the patient’s husband, called the case “very dramatic.” The report, co-authored by Castellani, concluded that the woman, like the other person whose death was linked to lecanemab, had amyloid deposits surrounding many of her brain’s blood vessels.

It likely contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels.

Castellani, his co-authors, and other researchers say the newly disclosed death suggests that tPA and perhaps other, less potent blood thinners pose safety considerations for Alzheimer’s patients receiving the antiamyloid antibody drugs, including lecanemab.

The 30-page consent form for trial participants, obtained by Science, carries this warning about blood thinners: “You may continue with these medications, but you and the investigator should discuss the risk of bleeding since medications which prevent clots and [lecanemab] are both associated with a slight risk of bleeding in the brain.” It does not address tPA directly.

The woman’s husband says the events surrounding her death were fully disclosed to Great Lakes Clinical Trials, the Chicago-based contract research organization that administered lecanemab to his wife as part of the antibody’s international, multicenter study.

According to the husband, Ross said during the meeting that he had shared details of the case with Eisai Co., the Japanese company that originally developed lecanemab with the Swedish firm BioArctic and sponsored the trial with its U.S.

“[Regulators] should take this case report seriously into account, because we're talking about significant side effects,” says Andreas Charidimou, a neuroscientist at Boston University who examined the report on the woman’s death for Science.

Several physicians and researchers not involved in the trial or the woman’s care reviewed the case report at Science’s request and concurred with its findings that lecanemab likely contributed to her death.

He says although no single case provides proof of a harmful side effect, this death exposed “a very legitimate concern.” Nicoll called the combined use of lecanemab and blood thinners “something you would want to keep a close eye on” should the antibody achieve approval and wide use.

Still, one reason to think lecanemab contributed to the woman’s death is that her autopsy revealed widespread cerebral amyloid angiopathy (CAA), a condition in which amyloid deposits gradually replace the smooth muscle of blood vessel walls.

Castellani, Nicoll, and others who reviewed her case suspect CAA made her blood vessels vulnerable to weakening when lecanemab did what it is expected to do: strip amyloids from the brain.

Nearly half of Alzheimer’s patients also have CAA—including, according to STAT, the man whose death was previously linked to combining lecanemab and blood thinners.

Many Alzheimer’s patients with CAA also suffer from other ailments, such as atrial fibrillation, that are normally treated with blood thinners, says Matthew Schrag, a Vanderbilt University physician and neuroscientist who specializes in CAA and assessed the report on the woman’s death for Science.

Training physicians to interpret tests for CAA will be key to ensure that vulnerable Alzheimer’s patients and their caregivers are properly informed and warned about the possible hazards of lecanemab, Charidimou says.

Assuming a close look at Clarity AD’s data validates the companies’ press release, lecanemab could still help early Alzheimer’s patients who don’t have moderate or severe CAA, says University of Kentucky neuroscientist Donna Wilcock, who also reviewed the report on the death?

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