Earlier this year, the developer of a promising antibody designed to slow Alzheimer’s disease strengthened a key warning given to participants in an ongoing trial of the experimental drug.
Taking the antibody alongside blood clot medications, the Japanese biotech company Eisai cautioned, increases the risk of possibly fatal brain hemorrhages. That revision of its informed consent form, revealed in a 14 July version obtained by, appears to challenge the company’s contention that the antibody, known as lecanemab, played no role in the recently revealed deaths of two people who suffered dramatic brain bleeds while concurrently taking the drug and blood thinners.
But his wife quickly began screaming, suffered seizures, was put on a ventilator, and died a few days later. An autopsy revealed a massive brain hemorrhage. At a highly anticipated November scientific meeting where Eisai provided its most detailed results so far on the lecanemab trial, the company noted in a presentation slide that people in the extension phase were “allowed to continue on anticoagulation … with informed consent language regarding increased risk of cerebral hemorrhage with concomitant anticoagulant use.
That’s why supporters of the so-called amyloid hypothesis were thrilled by the results of the recently completed phase 3 lecanemab trial, which included about 1800 people with early signs of Alzheimer’s. On average, those who received infusions of the antibody declined cognitively 27% more slowly than those on a placebo—the most beneficial response so far for an antiamyloid treatment.
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