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Report shares new details about deaths that may be linked to Alzheimer’s drug

Report shares new details about deaths that may be linked to experimental Alzheimer’s drug

 




CNN

Deaths in participants in a clinical trial of an antibody treatment for Alzheimer’s disease now under review by the U.S. Food and Drug Administration may be linked to an drug, a new report shows.

A research letter published Wednesday in the New England Journal of Medicine shares details about what happened to participants during the open-label extension phase of the lecanemab trial.

There is no placebo arm in the open-label extension. Rather, all participants will take the drug in question because the trials showed so many possibilities in the early stages.

In this case, a 65-year-old man who was in the early stages of Alzheimer’s disease was rushed to the emergency room of a Chicago-area hospital within 30 minutes of the first signs of a stroke, the report said. Physicians at Northwestern University Feinberg School of Medicine learned that the patient had received an infusion of lecanemab four days earlier.

This patient wasn’t the only one to die during an open arm extension. The health publication Stat reported investigators told of the death of another participant who had a brain hemorrhage that could be drug-related. teeth, Other possible factors.

Lecanemab is intended to slow the progression of Alzheimer’s disease. in November, company Published study showing it slows the progression of dementia 27% decrease compared to placebo. It also reduced levels of amyloid, a protein that is one of the hallmarks of Alzheimer’s disease, and had a positive effect on cognition and the ability to perform daily tasks compared to placebo.

The study also showed that about 2.8% of trial participants who took the drug had a symptomatic side effect called ARIA-E, involving swelling of the brain. None of the participants who received the placebo had it.

According to a new report, the hospital’s medical team gave the patient a common drug called a t-PA bolus to break up blood clots that can cause strokes. There was nothing in the patient’s medical background to suggest there was a problem with the drug, but less than an hour after starting treatment, his blood pressure soared, and the doctor stopped the infusion. Did.

A CT scan showed massive bleeding in the brain.

Doctors then administered medication to control the bleeding, but the patient became very upset and had communication problems. The patient also had frequent nonconvulsive seizures.

A medical team was able to treat the seizure, but the patient’s condition did not improve.

After three days in the hospital, the patient had a tube inserted into his trachea to help him breathe. Despite that and other supportive care, the patient died.

An autopsy showed that the patient had extensive cerebral hemorrhage and that many blood vessels in the brain had amyloid deposits, which was probably the cause of the hemorrhage, the report said.

Essentially, the report states that the blood vessels in the patient’s brain must have ruptured after being exposed to the thrombotic drug t-PA.

“The variability in the number and size of cerebral hemorrhages in this patient is unusual for a complication of t-PA associated solely with cerebrovascular amyloid,” said the report. However, the combination of thrombolytics and lecanemab may have caused cerebral hemorrhage.

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.”

Eisai said it did not provide an official response due to patient privacy.

The company and Northwestern Medicine pointed to published responses along with new reports from clinicians and researchers involved in clinical trials of lecanemab.

Doctor. In their response, Marwan Sabbagh and Christopher H. van Dyck wrote, “We agree that this case raises important management issues for Alzheimer’s patients.”

This “is an unusual case and we understand why the authors want to highlight a potential concern,” they said.

Their responses also pointed to other potential factors in the deaths of both study participants.

In this case, the cerebral hemorrhage may be related to the post-stroke period when the patient’s blood pressure was very high, they said. I was on medication, which may have contributed.

The doctor also wrote in an answer that another patient who received t-PA died from these amyloid deposits in the blood vessels of the brain.

Dr. Sharon Cohen, a behavioral neurologist who works with Alzheimer’s patients at the Toronto Memory Program and an investigator in the lecanemab trial, says developing treatments for Alzheimer’s disease is challenging.

Cohen said doctors have known for years that almost all drugs in this class can have the side effect of ARIA, which describes amyloid-related imaging abnormalities.

The drug’s safety “appears to be very acceptable,” she said. ”

Bleeding rates in trials are thought to be very low, and most of the microbleeds seen in trials are asymptomatic.

For the patients in the new report, Cohen thinks the deaths were probably related to blood-clotting drugs, but the combination of that drug and lecanemab “gives us pause.”

If the FDA approves a treatment, there is some latitude in patient selection and what the prescribing physician feels is best for people taking anticoagulants or other risk factors for bleeding. She said there is.

In general, lecanemab has exceeded our expectations in many ways, she said.

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