The death of a participant in a clinical trial of an antibody treatment for Alzheimer’s disease, which is now under consideration by the US Food and Drug Administration, may be linked to the experimental drug, a new report shows.
The research letter, published Wednesday in the New England Journal of Medicine, shares details about what happened to the participant in the open-label extension phase of the trial of lecanemab. In an open-label extension, there is no placebo arm; rather, all the participants get the medication in question because an earlier part of the trial has shown so much potential.
“The extensive number and variation in sizes of the cerebral hemorrhages in this patient would be unusual as a complication of t-PA solely related to cerebrovascular amyloid,” the report says. But the combination of the clot-busting drug with lecanemab may have led to the cerebral hemorrhages. Northwestern Medicine declined CNN’s request to interview the authors of the new report but said in a statement that it was “an effort to provide relevant data to the medical and scientific community.
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