The purpose of this study will be to evaluate the safety and tolerability of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).
This will be a multicenter, double-blind, randomized, placebo-controlled study in subjects with mild to moderate Alzheimer's disease. The study will comprise separate single dose ascending (SAD) and multiple dose ascending (MAD) parts designed to allow the MAD part to be initiated while the SAD part is ongoing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Lecanemab Single Dose Ascending Single intravenous infusions at sequentially ascending doses on Day 1 (dose levels: 0.1, 0.3, 1, 3, 10, and 15 mg/kg)
Placebo Matching Placebo Infusion
Lecanemab Multiple Dose Ascending Intravenous infusions once every 4 weeks at sequentially ascending doses (dose levels: 0.3, 1, 3, and 10 mg/kg)
Unnamed facility
Garden Grove, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Single Ascending Dose (SAD)
To evaluate the safety and tolerability of single intravenous (i.v.) infusions of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD)
Time frame: baseline to Day 180 post-dose
Multiple Ascending Dose(MAD)
To evaluate the safety and tolerability of 4 monthly i.v. infusions of lecanemab at sequentially ascending doses in subjects with AD
Time frame: baseline to Day 264 post-dose
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Placebo Matching Placebo Infusion
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Eatontown, New Jersey, United States
Unnamed facility
Princeton, New Jersey, United States
Unnamed facility
Salt Lake City, Utah, United States