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
Overview
- Phase
- Phase 1
- Intervention
- BAN2401 2.5 mg/kg
- Conditions
- Alzheimer's Disease
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 26
- Primary Endpoint
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BAN2401 2.5 mg/kg
Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401
Intervention: BAN2401 2.5 mg/kg
BAN2401 5 mg/kg
Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401
Intervention: BAN2401 5 mg/kg
BAN2401 10 mg/kg
Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401
Intervention: BAN2401 10 mg/kg
Placebo
Intravenous infusions of placebo for 60 +/- 10 minutes.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 14 weeks
Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs; laboratory parameters (hematology, blood chemistry, and urinalysis); vital signs; electrocardiograms; and physical examination; as well as a risk of suicide using C-SSRS and brain MRI.
Secondary Outcomes
- Pharmacokinetics of BAN2401: Maximum Concentration (Cmax)(Up to 14 weeks)
- Pharmacokinetics of BAN2401: time attain to Cmax (tmax)(Up to 14 weeks)
- Pharmacokinetics of BAN2401: Area under the curve (AUC)(Up to 14 weeks)
- Pharmacokinetics of BAN2401: Drug Clearance (CL)(Up to 14 weeks)
- Pharmacokinetics of BAN2401: apparent volume of distribution at steady state (Vss)(Up to 14 weeks)
- Investigation of the effect of repeated intravenous infusions of BAN2401 on the immunogenicity and CSF biomarkers(Up to 14 weeks)
- Investigation of the effect of apolipoprotein allele4 (ApoE4) on the safety, tolerability and pharmacodynamic (PD) response of repeated intravenous infusions of BAN2401(Up to 14 weeks)