12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease

Summary

This is a 12-month, single-arm, real-world study designed to evaluate the efficacy and safety of lecanemab (10 mg/kg administered every two weeks) in patients with early Alzheimer's disease, including mild cognitive impairment (MCI) due to AD or mild AD dementia, confirmed by amyloid-positive Aβ-PET scans. The study will enroll 80 participants, with both retrospective and prospective data collection.

Timeline

Start

2024-02-01

Primary completion

2026-01-01

Completion

2026-01-01

Publications

• Kang W, Gao C, Li X, Wang X, Zhong H, Wei Q, Tang Y, Huang P, Shen R, Chen L, Zhang J, Fang R, Wei W, Zhang F, Zhou G, Yuan W, Chen X, Yang Z, Wu Y, Xu W, Zhu S, Zhang L, He N, Fang W, Zhang M, Zhang Y, Ju H, Bai Y, Liu J. Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study. Chin Med J (Engl). 2025 Nov 20;138(22):2907-2916. doi: 10.1097/CM9.0000000000003888. Epub 2025 Oct 27.

Drugs

Indications