Efficacy and safety of lecanemab monoclonal antibody in the treatment of mild to moderate Alzheimer’s disease: a systematic review and meta-analysis
Abstract
Lecanemab is a novel therapy for Alzheimer’s disease (AD), but comprehensive evidence is lacking. This systematic review and meta-analysis evaluated the efficacy and safety in AD.
Registered in PROSPERO (CRD420251146867). PubMed, Embase, Cochrane Library, Web of Science, and Scopus were searched for English-language RCTs. Efficacy and safety were evaluated using the risk difference with a Mantel-Haenszel fixed-effects model. Study quality and sensitivity were assessed using Cochrane risk-of-bias and leave-one-out methods. Primary outcomes: mean changes in Alzheimer’s Disease Composite Score (ADCOMS), Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and amyloid burden on positron emission tomography (PET). Secondary: adverse events including amyloid-related imaging abnormalities with edema (ARIA-E), ARIA with hemorrhage (ARIA-H), death, treatment-emergent adverse events (TEAEs), headache, dizziness, and urinary tract infection.
A total of five articles involving 8 clinical trials were included. Based on the fixed-effect model, lecanemab treatment significantly improved cognitive performance on ADCOMS (SMD -0.1999, 95% CI [-0.2831, −0.1167], I
2
= 0%,
P
< 0.00001), CDR-SB (SMD −0.1853, 95% CI [−0.2683, −0.1024], I
2
= 0%,
P
< 0.0001), ADAS-Cog (SMD −0.1821, 95% CI [−0.2670, −0.0973], I
2
= 0%,
P
< 0.0001) and amyloid burden on PET (SMD −1.1872, 95% CI [−2.2474, −0.1270], I
2
= 96%,
P
= 0.03). Sensitivity…
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Evidence Hub reads this as a meta-analysis. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
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