NCT07153848

An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease

A Multicenter Cohort Study for Early Alzheimer's Disease in Zhejiang: an Observational Study on Lecanemab Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.

Detailed description

This study was a prospective observational study of a patient population treated or planning to be treated with lencanemab from a multicenter cohort of patients with early-stage AD in Zhejiang Province. It was a real-world study based on the treatment of lencanemab. The primary enrollment population was patients with mild AD or mild AD-origin cognitive disorders who had completed positive Aβ-PET scans that met the PET quality-control criteria and who were receiving treatment with lencanemab. Patients with cognitive impairment were divided into two subgroups: those receiving donepezil treatment alone and those receiving lencanemab combined with standard treatment with donepezil. Fresh plasma was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively. Amyloid PET scanning was performed at 12 months of follow-up and 18 months of follow-up. In order to evaluate the sensitivity and specificity of different blood biomarkers for monitoring and assessing the alleviation of amyloid pathology progression by Aβ-PET-confirmed lencanumab treatment, blinded peripheral blood AD core marker assays were performed in the main central laboratory. Furthermore, the aim was to provide a follow-up tool suitable for clinical blood marker-based monitoring of lencanumab treatment.

Conditions

• Alzheimer Disease

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2025-12-31
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

2 sites across 1 country: China