Randomized Study of Lecanemab for Treatment of Early to Moderate Alzheimers Disease Using Multi-omics and Imaging Approaches

What this Trial Is About

Researchers are conducting a multi-center, randomized trial to evaluate the efficacy and safety of Lecanemab in patients with early-to-moderate Alzheimers Disease. The study integrates multiple omics data, including eye imaging OCTOCTA and brain MRI, along with cognitive tests such as ADAS-Cog, MoCA, and CDR scores. Monitoring for ARIA, a significant safety concern in amyloid-targeting therapies, is also a key focus. Participants will be randomly assigned to either receive Lecanemab via intravenous infusion at a dose of 10 mgkg or conventional anti-dementia treatment, which typically involves cholinesterase inhibitors like donepezil. Lecanemab is administered over 60 minutes with a specialized infusion system. The study lasts 24 months, with evaluations at baseline, 6, 12, 18, and 24 months. During the trial, participants will undergo various assessments including amyloid PET scans to measure brain amyloid changes, retinal and cerebral imaging, and cognitive evaluations at multiple time points. Researchers will track changes in brain structure and function through MRI and monitor safety through clinical evaluations. The study aims to provide detailed insights into Lecanemabs impact on Alzheimers progression and patient cognition over two years.

Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs