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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07505095
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Lecanemab 10 mg/kg — DRUG
    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.
  • Lecanemab 5-10mg/kg — DRUG
    Lecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
140 participants (estimated)

Arms

  • Arm: Standard-Dose Treatment Group
    lecanemab 10mg/kg
  • Arm: Low-Dose Treatment Group
    lecanemab 5-10mg/kg

Primary Outcome Measure

Aβ-PET centiloid values [ Time Frame: Baseline, 18 months ]

Central Contacts

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