The experimental drug lecanemab shows 'potential' as an Alzheimer's disease treatment, according to new Phase 3 trial results, but the findings raise some safety concerns because of its association with certain serious adverse events.
A new study shows the drug called Lecanemab reduced symptoms of the disease by 27%, but researchers cautioned it had some side effects.treatment, according to new Phase 3 trial results, but the findings raise some safety concerns because of its association with certain serious adverse events.
"In persons with early Alzheimer's disease, lecanemab reduced brain amyloid levels and was associated with less decline on clinical measures of cognition and function than placebo at 18 months but was associated with adverse events," the researchers wrote. "Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer's disease."
"Significant differences emerge as early as the six-month timepoint," Dr. Christopher van Dyck, an author of the study and director of the Yale Alzheimer's Disease Research Center, said Tuesday during a presentation at the Clinical Trials On Alzheimer's Disease Conference in San Francisco."The lecanemab treatment met the primary and secondary endpoints," he said.
The most common adverse events in the drug group were reactions to the intravenous infusions and abnormalities on their MRIs, such as brain swelling and brain bleeding called amyloid-related imaging abnormalities, or ARIA. The researchers also wrote that about 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths documented in the lecanemab group and seven in the placebo group. "No deaths were considered by the investigators to be related to lecanemab or occurred with ARIA," they wrote.
"The FDA is expected to decide whether to grant accelerated approval to lecanemab by January 6, 2023," the Alzheimer's Association statement says. "Should the FDA do so, the currentpolicy will prevent thousands and thousands of Medicare beneficiaries with a terminal, progressive disease from accessing this treatment within the limited span of time they will have to access it.
"This is just the first chapter in what I hope to become a really long book in disease-modifying therapies for Alzheimer's disease," he said.
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