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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose study in a total of 24 subjects (8 subjects per cohort) with MCI due to AD and mild AD. The study consists of three cohorts to evaluate the safety, tolerability and PK of BAN2401 at three dose levels (2.5, 5, and 10 mg/kg). Each cohort consists of Screening Period before randomization, Treatment Period from randomization to last dose, and Follow-up Period after last dose. Cohorts 1, 2, and 3 will receive 2.5 mg/kg, 5 mg/kg, and 10 mg/kg of BAN2401, respectively.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	BAN2401 2.5 mg/kg	Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401 for 60 +/- 10 minutes.
DRUG	BAN2401 5 mg/kg	Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401 for 60 +/- 10 minutes.
DRUG	BAN2401 10 mg/kg	Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401 for 60 +/- 10 minutes
DRUG	Placebo	Intravenous infusions of placebo for 60 +/- 10 minutes.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2014-03-24
• Last updated: 2015-06-08

Locations

4 sites across 1 country: Japan