The experimental drug lecanemab shows “potential” as an Alzheimer’s disease treatment, according to new Phase 3 trials, but the results raise some safety concerns because of its association with some adverse effects.
The Phase 3 trial was conducted at 235 sites in North America, Europe, and Asia from March 2019 through March 2021. It involved 1,795 adults, aged 50 to 90, with mild cognitive impairment due to early Alzheimer’s disease or mild Alzheimer’s disease-related dementia.
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Lecanemab is a monoclonal antibody, that works by binding to amyloid beta, a hallmark of degenerative brain disorder. Lecanemab has become one of the first experimental dementia drugs to show the slowing of the progression of cognitive decline.
According to the trial data published Tuesday in the New England Journal of Medicine, a Phase 2 trial did not show a significant difference between lecanemab and placebo in Alzheimer’s disease patients in 12 months but the Phase 3 trial data shows that at 18 months, lecanameb was associated with more clearance of amyloid and less cognitive decline.
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At the start of the study, the participants’ average amyloid level was 77.92 centiloids in the lecanemab group and 75.03 centiloids in the placebo group. According to the research, by 18 months the average amyloid level slipped 55.48 centiloids in the lecanemab group and went up by 3.64 centiloids in the placebo group.
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Drug manufacturers Eisai and Biogen hired 1,795 people with earlier Alzheimer’s disease and amyloid beta in the brain. Participants were given either a 10 mg per kilogram, dose every two weeks over 18 months or a placebo.
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As per the study people with early signs of the mind-robbing disease who took the drug experienced “moderately less decline on measures of cognition and function” as compared to a placebo group. The researchers said the drug was associated with adverse events such as brain swelling and bleeding.
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People on the drug showed a slightly higher rate of side effects than those on a placebo. Around one in four people on the drug had infusion-related reactions and more than 1 in 10 reported brain swelling and bleeding revealed during brain scans.
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Less than 1% of trial participants reported irregular or rapid heartbeats, chest pain, or fainting. Side effects made 6.9% of people on the drug drop out of the study or more than twice the 2.9% from the control group.