Dubai, United Arab Emirates (CNN) – A monoclonal antibody treatment for Alzheimer’s disease that looked promising in a phase 3 clinical trial may have contributed to the death of one of the study participants, according to an adverse events report published by the Statistica digital health platform.
In a statement to CNN Friday, Esai, which makes the investigational drug lecanemab, said that to protect patients’ problems, it cannot provide specific patient information or comment on information from other sources.
The statistical platform reported that one of the study investigators told Esai of the death and that it was caused by a brain hemorrhage. The investigator concluded that the cause of the bleeding was related to the drug, but the company indicated other possible factors.
The company told Stat there was a “reasonable possibility that lecanemab may have contributed” to the bleeding. And that there may be other participant-related factors in the experiments, such as “frequent falls, heart attacks, respiratory infections, and mini-stroke-like accidents,” according to Stat. The participant in question was also taking anticoagulants due to her heart condition, according to the adverse event report that Stat reported looking into. It was reported on the Stat platform that the causes of death are still under investigation.
“What Stat has published is generally accurate in terms of how difficult it is to know the exact cause of a patient’s death, especially when the patient is elderly and has multiple medical problems,” Isai said in a statement.
The company explained that it has adopted a rigorous security monitoring process to ensure the safety of participants, including the formation of an independent data integrity monitoring committee composed of external experts, and added that it immediately sent security information. to investigators, regulators and participants.
And the company added that in the second phase of the clinical trials, the death rate among participants who received the drug was “common” compared to those who received a placebo.
“The well-being of patients enrolled in our clinical trials has always been a top priority for Isai,” the statement also states.
Dixie Ecklund, president-elect of the Association for Clinical Trials, which is not affiliated with Eisai and is not involved in clinical trials, acknowledged that the possibility of death is certainly in the context of a new drug trial, but believes that clinical trials they are essential “because with scientific rigor you can plan the tests well, get answers and thus make a difference in society”.
He also noted the importance of having an external panel to monitor data integrity in this experiment, as these recommendations are “very strict on scientific rigor”.
“There are many built-in checks and balances in the clinical trial industry in the United States between the FDA, the National Institutes of Health, and peer review that can give an individual the ability to make responsible assessment.”
In September, Esai reported preliminary results from a study that found that the treatment slowed the progression of cognitive decline by 27 percent compared to a placebo.
They also met all secondary endpoints and showed “goal adherence” with lower levels of amyloid, a protein that is a hallmark of Alzheimer’s disease, and positive effects on cognition and the ability to perceive and perform daily activities. compared to placebo.
The company said at the time that it believes the study results “provide the amyloid hypothesis, in terms of abnormal accumulation of beta-amyloid protein in the brain, a major cause of Alzheimer’s disease.”
Dr. Richard Isaacson, director of Alzheimer’s Prevention Clinic at the Center for Brain Health at Florida Atlantic University’s Schmidt School of Medicine, told CNN in September that this wasn’t proof in itself, but the process was significant.
“In the past, lower brain amyloid levels weren’t always associated with cognitive enhancement or significant clinical improvement. And in this study, every positive end point was the result. This is something we’ve never seen before,” he explained.
Preliminary results showed that about 2.8% of study participants who took the drug had a side effect called ARIA-E, or swelling in the brain, but this was not the case in those who took the placebo.
The rate of symptomatic ARIA-H, cerebral hemorrhage, and tissue iron accumulation was 0.7% in the drug group and 0.2% in the placebo group. Isai will present drug study results at the Alzheimer’s Clinical Trials Conference in late November.
Eisai, who works with Biogen, said it plans to publish the results in a journal after undergoing peer review and approval by U.S. regulators by the end of March.
