Summary

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• This summary is based on the review of 10 systematic reviews/meta-analyses. ^[1-2]
• Lecanemab significantly reduced brain amyloid-beta plaques, with a difference of 0.45 (95% confidence interval (CI), 0.67 to 0.23; P < 0.001), and moderately slowed clinical progression in patients with amyloid pathology, with a standardized mean difference (SMD) of -0.194 (95% CI, -0.279 to -0.108). Additionally, it demonstrated positive effects on cognitive outcomes, including the Alzheimer’s Disease Composite Score (ADCOMS), Clinical Dementia Rating-Sum of Boxes (CDR-SB) (P = 0.01), and Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog14) scores.
• Lecanemab showed beneficial effects in reducing the accumulation of beta-amyloid and cognitive decline, with improvements in cognitive and functional scales, although these changes were below the Minimal Clinically Important Difference (MCID).
• The effectiveness of lecanemab was primarily observed in early-stage Alzheimer’s Disease (AD) patients, particularly those with mild cognitive impairment or mild dementia and amyloid pathology. Subgroup analysis indicated potential considerations based on Apolipoprotein E4 (APOE4) genetic status for patient selection.
• Lecanemab was associated with a higher frequency of Amyloid-Related Imaging Abnormalities (ARIA), particularly ARIA-Hemorrhage (ARIA-H) (17.3% vs. 9.0%) and ARIA-Edema (ARIA-E) (12.6% vs. 1.7%) compared to placebo. Common adverse events included headache, infusion-related reactions, and ARIA-E.
• Lecanemab showed no significant difference in the occurrence of serious adverse events compared to placebo in early Alzheimer’s disease patients. However, the risks of ARIA-E (relative risk (RR) = 10.29; number needed to harm (NNH) = 9) and ARIA-H (RR = 1.74; NNH = 13) were notably increased.
• Specific safety concerns related to ARIA were more pronounced in patients with amyloid pathology, and APOE4 genetic status may influence the safety profile and treatment response in these patients.
• Lecanemab studies primarily focused on early-stage AD patients, particularly those with mild cognitive impairment or mild dementia, and with confirmed amyloid pathology. Subgroup analyses highlighted the relevance of the APOE4 genetic status, which may influence both treatment efficacy and safety outcomes.