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This phase 3, multicentre, double-blind, randomized, placebo-controlled CLARITY AD trial evaluated the efficacy and safety of lecanemab, a humanized IgG1 monoclonal antibody that selectively binds soluble amyloid-β protofibrils, in adults aged 50–90 years with early Alzheimer’s disease, including mild cognitive impairment or mild dementia and confirmed amyloid pathology. A total of 1,795 participants were enrolled across 235 sites and randomized in a 1:1 ratio to receive intravenous lecanemab 10 mg/kg every two weeks (n=898) or placebo (n=897) for 18 months. The primary endpoint was change from baseline in the Clinical Dementia Rating–Sum of Boxes (CDR-SB) score, which ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment. Key secondary endpoints included change in brain amyloid burden measured by positron emission tomography (PET), Alzheimer’s Disease Assessment Scale–Cognitive Subscale 14 (ADAS-Cog14), Alzheimer’s Disease Composite Score (ADCOMS), and Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL). At baseline, the mean CDR-SB scores were 3.17 in the lecanemab group and 3.22 in the placebo group. At 18 months, the adjusted mean CDR-SB score increased by 1.21 points with lecanemab compared with 1.66 points with placebo, yielding a between-group difference of −0.45 points
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This phase 3, multicentre, double-blind, randomized, placebo-controlled CLARITY AD trial evaluated the efficacy and safety of lecanemab, a humanized IgG1 monoclonal antibody that selectively binds soluble amyloid-β protofibrils, in adults aged 50–90 years with early Alzheimer’s disease, including mild cognitive impairment or mild dementia and confirmed amyloid pathology. A total of 1,795 participants were enrolled across 235 sites and randomized in a 1:1 ratio to receive intravenous lecanemab 10 mg/kg every two weeks (n=898) or placebo (n=897) for 18 months. The primary endpoint was change from baseline in the Clinical Dementia Rating–Sum of Boxes (CDR-SB) score, which ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment. Key secondary endpoints included change in brain amyloid burden measured by positron emission tomography (PET), Alzheimer’s Disease Assessment Scale–Cognitive Subscale 14 (ADAS-Cog14), Alzheimer’s Disease Composite Score (ADCOMS), and Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL). At baseline, the mean CDR-SB scores were 3.17 in the lecanemab group and 3.22 in the placebo group. At 18 months, the adjusted mean CDR-SB score increased by 1.21 points with lecanemab compared with 1.66 points with placebo, yielding a between-group difference of −0.45 points
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