drugset / Trial / NCT02094729

A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

NCT02094729

Phase 1 Completed 26 enrolled Eisai Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease.

Timeline

Start
2013-09
Primary completion
2015-03
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Lecanemab Monoclonal antibody 2.5 mg/kg Intravenous
Subject Lecanemab Monoclonal antibody 5 mg/kg Intravenous
Subject Lecanemab Monoclonal antibody 10 mg/kg Intravenous

Indications