NCT07034222

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

A 12-month Single-arm Real-world Study to Determine the Safety and Efficacy of Lecanemab in Patients With Early Alzheimer's Disease

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study enrolled participants with mild cognitive impairment due to AD or mild AD. All participants received biweekly intravenous infusions of lecanemab at a dose of 10 mg/kg. Safety data was collected, particularly for amyloid-related imaging abnormalities (ARIA). Effectiveness evaluations included cognitive tests, plasma biomarker analysis, and advanced neuroimaging.

Conditions

• Alzheimer's Disease(AD)

Interventions

Type	Name	Description
DRUG	Administer Leqemi 10 mg/kg, every two weeks.	Receive 10 mg/kg of Leqembi once every two weeks. Dissolve Leqembi in normal saline and administer it intravenously over 60 minutes. The infusion system must use a 0.2-μM terminal line filter for administration.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: China