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12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease
Sponsor: Ruijin Hospital
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.
Official title: A 12-month Single-arm Real-world Study to Determine the Safety and Efficacy of Lecanemab in Patients With Early Alzheimer's Disease
Key Details
Gender
All
Age Range
50 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-02-01
Completion Date
2026-01-01
Last Updated
2025-06-24
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China