NCT07505095

Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will analyze the clinical indicators, imaging data, and serum biomarkers of Alzheimer's disease (AD) patients receiving different doses of the medication before and after treatment. It aims to clarify whether the therapeutic efficacy in the low-dose group is equivalent to that in the recommended-dose group, and meanwhile to determine the optimal dose range for effective pharmacotherapy.

Conditions

• Alzheimer Disease (AD)
• Alzheimer Dementia
• MCI-AD, Early Stage Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Lecanemab 10 mg/kg	Lecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL.
DRUG	Lecanemab 5-10mg/kg	Lecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-04-30
• Completion: 2028-01-31
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: China