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Results from Eisai and Biogen’s Alzheimer's treatment, lecanemab, indicated significantly slowed cognitive decline in patients relative to placebo.
Eisai and Biogen announced results from Eisia’s global Phase III confirmatory Clarity Alzheimer’s disease (AD) clinical study of lecanemab on Nov. 29, 2022. Lecanemab is an investigational anti-amyloid beta protofibril antibody intended for the treatment of mild cognitive impairment (MCI) stemming from AD and mild AD (also known as early AD) with confirmed presence of amyloid pathology in the brain.
The study was a placebo-controlled, double-blind, parallel-group, randomized study of 1795 people with early AD in North America, Europe, and Asia. According to a company press release, the primary endpoint was change from baseline at 18 months in the clinical dementia rating sum of boxes (CDR-SB), a global cognitive and functional scale.
The mean change of CDR-SB in patients who received lecanemab was 1.21, while patients who received placebo had a mean change of 1.66, which the researchers found to be highly statistically significant. Key secondary endpoints, such as reduction in amyloid plaque burden, slowed decline of cognitive function on the Alzheimer’s disease assessment scale–cognitive subscale, and a decline of daily living activities, also showed statistically significant responses relative to placebo.
“Today’s exciting results offer our best hope yet for not only delaying symptom progression for people with early stage Alzheimer’s, but, significantly, slowing the loss of quality of life for them and their carers,” said Dr Richard Oakley, associate director of research, Alzheimer’s Society, in an agency press release concerning the findings.