An individual enrolled in a study involving a monoclonal antibody treatment for Alzheimer’s disease has reportedly died after taking an experimental drug.
The medication in query showed promise in a Phase 3 trial, but there may be now controversy over its use after one participant died in the middle of the study.
An adversarial events report released by the digital health publication Stat on Friday indicated that the experimental drug Iecanemab could have contributed to the patient’s death in June.
The publication’s investigator noted that the patient’s death got here after the participant experienced brain bleeding and concluded that it could possibly be related to the drug.
The corporate behind the drug, Eisai, admitted there was “no less than an inexpensive possibility Iecanemab can have contributed to the [hemorrhage].”
Nevertheless, it also insisted that other possible aspects could have led to the complication within the patient, including multiple falls, a heart attack, a mini-stroke and a respiratory infection.
Stat did say in its adversarial effects report that the patient was on blood thinners for a heart condition, so further investigation into the matter is required.
In an announcement to CNN, Eisai sai it couldn’t provide specific details about patients as a result of patient privacy issues. It also refused to comment on information from other sources.
But Eisai maintained that it had a rigorous safety monitoring system in place to ensure that every participant was protected through the trial.
“The well-being of the patients enrolled in our clinical studies is at all times Eisai’s top priority,” the corporate said within the statement.
The corporate will present the outcomes of the newest drug trial on the Clinical Trials on Alzheimer’s Disease conference in late November. Eisai will then publish the ends in a peer-reviewed journal by March 2023.
The president-elect of the Society for Clinical Trials, Dixie Ecklund, acknowledged via CNN that deaths could actually occur amid a recent drug trial. Hence, there may be a challenge for researchers to design trials well in order that they could make a difference in our society with very minimal risk.