Abstract Details

Title Efficacy and Safety of Lecanemab in Early Alzheimer's Disease: A Meta-analysis of Clinical Trials

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P2 - Poster Session 2 (11:45 AM-12:45 PM)

Poster/Presentation
Number 12-009

Objective This meta-analysis aims to synthesize evidence from clinical trials to quantify Lecanemab's efficacy on key cognitive, functional, and biomarker outcomes, and to determine the pooled incidence of its primary safety concerns, ARIA-E and ARIA-H.

Background Lecanemab, an anti-amyloid monoclonal antibody, has emerged as a promising disease-modifying therapy for early Alzheimer's disease. Clinical trials have evaluated its impact on various outcomes, including cognitive and functional decline, measured by CDR-SB, ADAS-Cog 14 and ADCOMS; amyloid plaque burden - Amyloid PET, and safety, particularly the incidence of and Amyloid-Related Imaging Abnormalities ARIA-E and ARIA-H. However, a consolidated view of its effect size across studies is essential for clinical context.

Design/Methods We performed a random-effects meta-analysis on published clinical trials reporting outcomes for Lecanemab versus placebo. We analyzed the mean difference (MD) for efficacy outcomes and the pooled proportion for safety events. Heterogeneity was assessed using the I² statistic.

Results Six studies including 4,862 patients were analyzed. Lecanemab significantly slowed cognitive decline with low heterogeneity on the CDR-SB (MD -0.48, 95% CI: -0.80 to -0.15, p<0.05, I²=0%), ADAS-Cog 14 (MD -1.36, 95% CI: -1.79 to -0.94, p<0.01, I²=0%) and ADCOMS (MD -47.92, 95% CI: -53.59 to -42.24, p < 0.01, I² = 98%). It also showed a substantial reduction in amyloid plaque burden on PET scans (MD -54.58, 95% CI: -150.94 to 41.78, p = 0.13, I² = 96%). The pooled incidence of ARIA-E was 13% (95% CI: 11% to 14%) with low heterogeneity (I²=10%), while the incidence of ARIA-H was 11% (95% CI: 7% to 15%) with high heterogeneity (I²=86%).

Conclusions This meta-analysis confirms that Lecanemab provides statistically significant clinical benefits in slowing cognitive decline and reducing amyloid pathology in patients with early Alzheimer's disease. These benefits must be weighed against a notable risk of ARIA, highlighting the critical need for careful patient selection and safety monitoring.

Authors/Disclosures
Marianna Leite PRESENTER	Miss Leite has nothing to disclose.
Anderson Matheus P da Silva, Sr., PhD	Prof. P da Silva has nothing to disclose.
Anderson S. Corin	Mr. Corin has nothing to disclose.
Abhishek Goyal, MD	Dr. Goyal has nothing to disclose.
João Vitor A. Fernandes, Medical Student	Mr. Fernandes has nothing to disclose.
Mariana Letícia d. Maximiano, MD	Dr. Maximiano has nothing to disclose.
Diogo Haddad Santos, MD (Moema)	Dr. Haddad Santos has nothing to disclose.
Carolina B. Moura, MD (Hospital Universitário Antonio Pedro)	Dr. Moura has nothing to disclose.

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