Eisai and Biogen share clinical trial data confirming that lecanemab slows mental decline amid reports of potentially related deaths
Researchers have got a first look at phase III clinical trial data for a much lauded experimental Alzheimer’s drug—and although the data support it having a moderate cognitive benefit for people, scientists worry about its safety.
“It’s quite a complicated balancing act for risks and benefits,” says Rob Howard, a psychiatrist at University College London who specializes in dementia. And he worries about how patients and families who are desperate for Alzheimer’s treatments will weigh the two sides, if lecanemab is approved by regulatory agencies.
Benefits and risks Researchers are glad to see the swift publication of the lecanemab trial data. Some have previously criticized the rollout of another monoclonal antibody treatment for Alzheimer’s: aducanumab. Like lecanemab, aducanumab was designed to sweep clumps of a protein called amyloid-β from the brain; many researchers think this protein is a root cause of Alzheimer’s.
But some researchers have questioned whether this shift is big enough to be noticeable in a person. A one-point difference on the CDR-SB is the minimum to be clinically important, Howard says. During Clarity AD, 13 people taking lecanemab developed symptomatic brain bleeds—or strokes—whereas only 2 people in the placebo group did, according to the conference presentation. This represents just 1.4% of the treatment group, Howard says, but “that’s not a trivial risk profile”.
Because of the tie with anticoagulants and other factors, it’s a bit difficult to detangle whether lecanemab played a role in the deaths, said Marwan Sabbagh, a neurologist at the Barrow Neurological Institute in Phoenix, Arizona, while presenting data at the conference. “These things are continuing to be explored,” he said. Although the rate of brain hemorrhage is low with lecanemab, it does rise with anticoagulants, he added.
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