An experimental Alzheimer’s drug may have caused the death of a study participant, according to reports




CNN

A monoclonal antibody treatment for Alzheimer’s disease that showed promise in a Phase 3 trial may have caused the death of a study participant, according to an adverse event report obtained by Stat, a digital health publication.

Eisai, the company that makes the experimental drug lecanemab, told CNN on Friday that it could not provide specific information about patients or comment on data from other sources due to patient privacy concerns.

Stat, an investigator involved in the investigation told Eisai that the death was the result of bleeding in the brain. An investigator concluded the bleeding was drug-related, but the company pointed to other possible factors.

The company told Stat that there is at least a reasonable possibility that lecanemab could cause bleeding. Other factors may include a participant’s “multiple falls, heart attacks, respiratory infections and mini-stroke-like events,” according to Stat. The participant in question was also taking blood thinners for a heart condition, Stat said, according to an adverse event report. Stat reports that the death is still under investigation.

“STAT News was clear about how difficult it can be to determine a specific cause of death in any given patient, especially when they are elderly and have multiple medical problems,” Eisai said.

The company said it has established a rigorous security monitoring process to make sure participants are safe, including an independent data security monitoring committee made up of outside experts and promptly communicating security information to investigators, regulators and participants.

The company added that in phase 2 of the trial, the death rate was “no more frequent” in participants taking the drug than in those taking a placebo.

“The well-being of patients enrolled in our clinical studies is always a top priority for Eisai,” he said.

Dixie Eklund, president-elect of the Society for Clinical Trials, acknowledged that deaths can certainly happen when testing a new drug, but believes that trials remain important: “Because with scientific rigor, you can design trials well and get answers, and then make a difference in our society. ” Eklund is not related to Eisai and has not participated in the lawsuits.

He points to the importance of an external data security monitoring board with this test, as these boards are “very particular about scientific rigor.”

“There are a lot of checks and balances built into the clinical trial industry between the FDA and the NIH in the United States, peer review, and all of that can affect an individual’s ability to make a responsible assessment.”

In September, Eisai reported preliminary results from a trial that found the treatment slowed the progression of cognitive decline by 27% compared to a placebo.

It also met all secondary endpoints, with reduced levels of amyloid “target marker” – a protein that is one of the hallmarks of Alzheimer’s – and a positive effect on cognition and the ability to perform daily tasks compared to placebo.

The company said at the time that the results of the study “prove the amyloid hypothesis that here [amyloid beta] presence in the brain is one of the main causes of Alzheimer’s disease.

Dr. Richard Isaacson told CNN in September that this is not evidence in itself, but that the trial is important. Isaacson is director of the Alzheimer’s Prevention Clinic at the Center for Brain Health at Florida Atlantic University’s Schmidt College of Medicine.

“In the past, reduction of amyloid in the brain was not always associated with cognitive improvement or any meaningful clinical improvement. Every endpoint in this study was positive. This has never happened before.”

Early results showed that about 3% of trial participants who took the drug had a side effect called ARIA-E, which is swelling in the brain, but no one who took a placebo did.

The rates of symptomatic ARIA-H, cerebral hemorrhage, and tissue iron accumulation were 0.7% in the drug group and 0.2% in the placebo group.

Eisai will present the results of the drug trials at the Alzheimer’s Disease Clinical Trials conference in late November.

Eisai, who is working with Biogen, said they plan to publish the results in a peer-reviewed journal and receive approval from US regulators by the end of March.



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