Did Experimental Alzheimer’s Drug Contribute To Study Participant’s Death?

A person enrolled in a study involving a monoclonal antibody treatment for Alzheimer’s disease has reportedly died after taking an experimental drug.

The medication in question showed promise in a Phase 3 trial, but there is now controversy over its use after one participant died in the course of the study.

An adverse 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 came after the participant experienced brain bleeding and concluded that it could be related to the drug.

The company behind the drug, Eisai, admitted there was “at least a reasonable possibility Iecanemab may have contributed to the [hemorrhage].”

However, it also insisted that other possible factors could have led to the complication in the patient, including multiple falls, a heart attack, a mini-stroke and a respiratory infection.

Stat did say in its adverse effects report that the patient was on blood thinners for a heart condition, so further investigation into the matter is needed.

In a statement to CNN, Eisai sai it could not provide specific information about patients due to 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 make sure that each participant was safe during the trial.

“The well-being of the patients enrolled in our clinical studies is always Eisai’s top priority,” the company said in the statement.

The company will present the results of the latest drug trial at the Clinical Trials on Alzheimer’s Disease conference in late November. Eisai will then publish the results 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 certainly happen amid a new drug trial. Hence, there is a challenge for researchers to design trials well so they can make a difference in our society with very minimal risk.