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 | Completed Phase 1

• 1 other identifier: BAN2401-J081-104
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

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.

Conditions

Alzheimer's Disease

Keywords

mild cognitive impairment; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  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.

  Up to 14 weeks

Secondary Outcomes (7)

• 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

Study Arms (4)

BAN2401 2.5 mg/kg

EXPERIMENTAL

Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401

Drug: BAN2401 2.5 mg/kg

BAN2401 5 mg/kg

EXPERIMENTAL

Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401

Drug: BAN2401 5 mg/kg

BAN2401 10 mg/kg

EXPERIMENTAL

Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401

Drug: BAN2401 10 mg/kg

Placebo

PLACEBO COMPARATOR

Intravenous infusions of placebo for 60 +/- 10 minutes.

Drug: Placebo

Interventions

BAN2401 2.5 mg/kg DRUG

Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401 for 60 +/- 10 minutes.

BAN2401 2.5 mg/kg

BAN2401 5 mg/kg DRUG

Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401 for 60 +/- 10 minutes.

BAN2401 5 mg/kg

BAN2401 10 mg/kg DRUG

Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401 for 60 +/- 10 minutes

BAN2401 10 mg/kg

Placebo DRUG

Intravenous infusions of placebo for 60 +/- 10 minutes.

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MCI due to AD
• Subjects who have clinical and cognitive symptoms consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) core criteria for MCI
• Subjects who have a Clinical Dementia Rating (CDR) of 0.5 and a memory box score of 0.5 or greater at Screening
• Subjects who report a history of subjective memory decline with slow progression at least 1 year before Screening, or subjects whose information provider or attending physician reports a history of memory decline with slow progression at least 1 year before Screening
• Subjects with objective impairment in episodic memory as indicated by 1-1.5 standard deviations below age-adjusted mean in the Wechsler Memory Scale-Revised (WMS-R) logical memory II (delayed recall) at Screening:
• less than or equal to 15 for age 50 to 64 years
• less than or equal to 12 for age 65 to 69 years
• less than or equal to 11 for age 70 to 74 years
• less than or equal to 9 for age 75 to 79 years
• less than or equal to 7 for age 80 to 90 years
• Mild AD
• Subjects who meet the NIA-AA core clinical criteria for probable AD
• Subjects who have a CDR of 0.5 or 1.0 and a memory box score of 0.5 or greater at Screening
• All subjects
• Male or female subjects aged between 50 and 90 years, inclusive, at obtaining informed consent

You may not qualify if:

• Any neurological condition that may affect cognitive impairment
• History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
• Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
• Any medical devices contraindicated for MRI scanning (e.g., cardiac pacemaker/defibrillator, ferromagnetic metal implants, any devices other than those approved as safe for use in MRI scanners)
• Evidence of infection, tumor, stroke or other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening
• Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening
• A prolonged QT interval (QTcF greater than or equal to 450 ms) as demonstrated by a repeated ECG at Screening
• Any other clinically significant conditions (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments
• Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Kurashiki, Okayama-ken, Japan

Location

Unknown Facility

Koto-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

lecanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: March 24, 2014
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

JP (4)