Alzheimer’s drug may benefit some patients, new data shows
Dr Thambisetty said the two deaths add to questions about the safety issues of lecanemab “in real-world clinical practice where patients are likely to be sicker and have multiple other medical conditions in contrast to carefully screened patients. in clinical trials”.
Nevertheless, data on lecanemab, which Dr. Gandy says attacks a different form of amyloid than the drugs previously tested, showed significantly lower rates of swelling and bleeding than with Aduhelm.
Nearly 13% of patients receiving lecanemab experienced brain swelling, which was mild or moderate in most cases, while less than 2% of patients receiving placebo experienced such swelling, according to the study. Most brain swellings caused no symptoms and usually resolved within a few months. About 17% of patients with lecanemab had a cerebral hemorrhage, compared to 9% of patients receiving placebo. The most common symptom of brain bleeds was dizziness, according to the study.
The authors reported that “serious adverse events” occurred in 14% of lecanemab-treated patients and 11% of those receiving placebo. Nearly 7% of lecanemab patients dropped out of the trial due to negative side effects, more than double the percentage of placebo recipients who dropped out. More than a quarter of patients with lecanemab experienced infusion-related adverse reactions, including fever and flu-like symptoms, usually after the first dose. A much lower percentage of placebo patients experienced these reactions, according to the study.
The primary positive outcome of the study was that patients with lecanemab declined cognitively by 1.21 points, while patients receiving placebo declined by 1.66 points on the 18-point scale, which assesses functions such as memory, problem solving and daily activities through interviews with patients and caregivers. .
This result was supported by secondary measures in the trial, including three other cognitive tests, bolstering the possibility that the drug had a real effect, the experts said. Additionally, on all measures, patients began to show a slower decline several months after starting lecanemab, and the rate slowed further over the 18-month trial.
The trial strived to include more participants of color than those typically enrolled in Alzheimer’s trials. About 25% of those who took part in the trial in the United States were black or Hispanic, according to the study. It also allowed people with various medical conditions to participate, including hypertension, diabetes, heart disease, obesity, and kidney disease.