A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: Active Comparator BDrug: Placebo Comparator BDrug: Placebo Comparator A
- Registration Number
- NCT01230853
- Lead Sponsor
- Eisai Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active Comparator: B Active Comparator B - Placebo Comparator B Placebo Comparator B - Placebo Comparator A Placebo Comparator A -
- Primary Outcome Measures
Name Time Method Single Ascending Dose (SAD) baseline to Day 180 post-dose 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)
Multiple Ascending Dose(MAD) baseline to Day 264 post-dose To evaluate the safety and tolerability of 4 monthly i.v. infusions of lecanemab at sequentially ascending doses in subjects with AD
- Secondary Outcome Measures
Name Time Method