Novel Alzheimer’s therapy shows low risk of severe side effects

The approval of the Food and Drug Administration in 2023 of Lecanemab – a new therapy from Alzheimer’s that was shown in clinical investigations into a modest slow disease progression – was received by many in the field of enthusiasm because it was able to influence the disease. But side effects – brain swelling and bleeding – arose during clinical studies that some patients and doctors have left about treatment.

Medications can have somewhat different effects as soon as they are released in the real world with wider demography. Researchers at the Washington University School of Medicine in St. Louis wanted to study the side effects related to Lecanemab in their clinic patients and discovered that significant side effects were rare and manageable.

In accordance with the results of carefully controlled clinical studies, researchers discovered that only 1% of patients experienced serious side effects that required hospitalization. Patients at the earliest stage of Alzheimer’s with very mild symptoms experienced the lowest risk of complications, the researchers who helped in informing patients and clinicians found discussions about the risks of treatment.

The retrospective study, published on 12 May in Jama Neurology, Focused on 234 patients with a very mild or mild disease from Alzheimer’s who received Lecanemab infusions in the Rein Diagnostic Center at Washu Medicine, a clinic specializing in the treatment of patients with dementia.

This new class drugs for early symptomatic Alzheimer’s is the only approved treatment that influences disease progression. But fear of the potential side effects of the drug can lead to treatment delays. Our study shows that the Washu Medicine outpatient clinic has the infrastructure and expertise to safely manage and care for patients on Lecanemab, including the few who can experience serious side effects, so that more clinics are administered for more clinics to safely administer the drug to patients. “

Barbara Joy Snider, MD, PhD, professor of neurology and co-senior author of the study

Lecanemab is an antibody therapy that cleans up amyloid plaque proteins, which expands by 10 months by 10 months, according to a recent study led by researchers of Washu Medicine. Because amyloid accumulation is the first step in the disease, doctors recommend the medicine for people at the early stage of Alzheimer’s, with very mild or mild symptoms. The researchers discovered that only 1.8% of patients with a very mild symptoms of Alzheimer’s developed any adverse symptoms of the treatment compared to 27% of patients with mild Alzheimer’s.

“Patients with the very mildest symptoms of Alzheimer’s are likely to have the biggest advantage and the least risk of side effects due to treatment,” said Snider, who led clinical examinations for Lecanemab at Washu Medicine. “Hesitation and avoidance can lead to patients slowing down the treatment, which in turn increases the risk of side effects. We hope that the results will help reformulate the conversations between doctors and patients about the risks of the drug.”

Hesitation around Lecanemab stems from a side effect that is known as amyloid-related imaging abnormalities, or Aria. The abnormalities, which usually only influence a very small part of the brain, appear on brain scans and indicate swelling or bleeding. In clinical studies with Lecanemab, 12.6% of the participants experienced Aria and most cases were asymptomatic and resolved without intervention. A small percentage – about 2.8% of the treated participants – experienced symptoms such as headache, confusion, nausea and dizziness. Incidental deaths are linked to Lecanemab in estimation 0.2% of the patients treated.

The Memory Diagnostic Center began to treat patients with Lecanemab in 2023 after the drug had received full FDA approval. Patients receive the medication through infusions every two weeks in infusion centers. As part of the care of each patient, Washu doctors regularly collect advanced imaging to control the brain that can detect bleeding and swelling with great sensitivity. Lecanemab is stopped in patients with symptoms of aria or significant aria without symptoms, and the rare patients with severe aria are treated with steroids in the hospital.

When looking back on the results of their patients, the authors found the degree of side effects tailored to those of the studies – most of the cases of Aria were asymptomatic and only discovered on sensitive brain scans used to follow brain changes. Of the 11 patients who have experienced Aria symptoms, the effects largely disappeared within a few months and no patients died.

“Most patients on Lecanemab tolerate the drug well,” says Suzanne Schindler, MD, PhD, associate professor of neurology and a co-senior author of the study. “This report can help patients and providers better understand the risks of treatment that are lower in patients with very mild symptoms of Alzheimer’s.”