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

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

May 31, 2015

Conditions
Alzheimer's Disease
Interventions
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.

Trial Locations (4)

Unknown

Kobe

Sendai

Kurashiki

Koto-ku

All Listed Sponsors
lead

Eisai Co., Ltd.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter