Promising data shows that an Alzheimer’s drug can slow cognitive decline.
In a phase III clinical trial, with results published Tuesday in The New England Journal of Medicine, the drug, Lecanemab — developed by Eisai and Biogen Inc. — slowed the rate of cognitive decline by 27% in patients in the early stages of the disease, making it the first drug of its kind to produce such positive trial results, a study showed.
Researchers followed nearly 1,800 patients over the course of 18 months and found the drug “resulted in moderately less decline on measures of cognition and function,” compared to patients who received a placebo.
However, the companies noted that “longer trials are warranted to determine the efficacy and safety of Lecanemab in early Alzheimer’s disease.”
A scientist works in a lab at Biogen Inc. in Cambridge, Mass., Nov. 5, 2016.
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Patients who have Alzheimer’s disease have build-up of two proteins, amyloid-beta and tau, in the brain. They clump together and form plaques, disrupting cell function and causing symptoms such as memory loss and confusion.
Lecanemab is a monoclonal antibody that helps remove the amyloid-beta clumps.
Trial participants were split into two groups, both with a Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score of about 3.2 when the trial began. This score, which measures dementia impairment, has a scale from 0 indicating no impairment to 18.0 indicating severe impairment. A score of 3.2 indicates very mild impairment.
Over the course of 18 months, patients in the Lecanemab group saw their score go up by 1.21 points in comparison with patients in the placebo group, who saw their score go up by 1.66 points.
There were some adverse events in the trial, the companies said, including patients who experienced brain swelling or brain bleeding.
Following the 18-month study, two patients died after experiencing brain hemorrhaging. However, Easi said no deaths are considered linked to Lecanemab.
What’s more, the Alzheimer’s Association said it was “encouraged” by the news and called on the U.S. Food and Drug Administration to give accelerated approval of Lecanemab.
A brain scan of a patient affected by Alzheimer’s disease.
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“These peer-reviewed, published results show Lecanemab will provide patients more time to participate in daily life and live independently,” the association said in a statement. “It could mean many months more of recognizing their spouse, children and grandchildren.”
The statement continued, “Treatments that deliver tangible benefits to those living with mild cognitive impairment (MCI) due to Alzheimer’s and early Alzheimer’s dementia are as valuable as treatments that extend the lives of those with other terminal diseases”