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Revised clinical trial form for Alzheimer’s antibody warned of fatal brain bleeds | Science | AAAS

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Revised clinical trial form for Alzheimer’s antibody warned of fatal brain bleeds | Science | AAAS


Science | AAAS


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 Science, 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.
 

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Another issue mentioned in this article:

“And three key trial subgroups—people under age 65, women, and people who carry two copies of APOE4, a gene variant that raises one’s risk of developing Alzheimer’s—did not show any statistically significant benefit.”