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A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01767311
First received: January 8, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of BAN2401 to determine clinical efficacy and to explore the dose response of BAN2401 using a composite clinical score. BAN2401-G000-201 is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of subjects and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of subjects. Subjects will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint.


Condition Intervention Phase
Alzheimer's Disease
Drug: BAN2401 2.5 mg/kg
Drug: BAN2401 5.0 mg/kg
Drug: BAN2401 10 mg/kg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer?s Disease

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Change from baseline in the derived Composite Clinical Score at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the derived Composite Clinical Score at 18 months [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in total hippocampal volume at 6, 12, and 18 Months using volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline and 6, 12, and 18 months ] [ Designated as safety issue: No ]
  • Change from baseline at 12 and 18 months in brain amyloid levels as measured by amyloid Positron Emission Tomography (PET) [ Time Frame: Baseline and 12 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAN2401 2.5 mg/kg biweekly
2.5 mg/kg biweekly
Drug: BAN2401 2.5 mg/kg
2.5 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
Experimental: BAN2401 5.0 mg/kg biweekly
5.0 mg/kg biweekly
Drug: BAN2401 5.0 mg/kg
5.0 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
Experimental: BAN2401 10 mg/kg biweekly
10 mg/kg biweekly
Drug: BAN2401 10 mg/kg
10 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
Experimental: BAN2401 5.0 mg/kg monthly
5.0 mg/kg monthly
Drug: BAN2401 5.0 mg/kg
5.0 mg/kg monthly (once every 4 weeks) administered as a 60 minute i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
Experimental: BAN2401 10 mg/kg monthly

10 mg/kg monthly

--------------------------------------------------------------------------------

Drug: BAN2401 10 mg/kg
10 mg/kg monthly (once every 4 weeks) administered as a 60 minute i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion criteria for Mild Cognitive Impairment due to Alzheimer's Disease

- intermediate likelihood:

  1. Subjects who meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment due to Alzheimer's disease - intermediate likelihood
  2. Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
  3. Subjects who report a history of subjective memory decline with gradual onset and slow progression over the last one year before Screening; MUST be corroborated by an informant
  4. Subjects with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale - IV Logical Memory II (WMS-IV LMII):

    1. Less than or equal to 15 for age 50 to 64 years
    2. Less than or equal to 12 for age 65 to 69 years
    3. Less than or equal to 11 for age 70 to 74 years
    4. Less than or equal to 9 for age 75 to 79 years
    5. Less than or equal to 7 for age 80 to 90 years

Key Inclusion criteria for Mild Alzheimer's Disease Dementia:

  1. Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
  2. Subjects who have a CDR score of 0.5-1.0 and a Memory Box score of 0.5 or greater at Screening and Baseline

Inclusion criteria that must be met by all subjects:

  1. Positive amyloid load as indicated by PET assessment
  2. Age between 50 and 90 years, inclusive
  3. Mini Mental State Examination (MMSE) score equal to or greater than 22, and equal to or less than 30, at Screening and Baseline
  4. Body Mass Index (BMI) less than 35 at Screening
  5. Females must not be pregnant or lactating, and specified contraceptive precautions must be followed
  6. Subjects on acetylcholinesterase inhibitor or memantine therapy for Alzheimer's disease (AD) must be on a stable dose for at least 12 weeks prior to baseline
  7. Subjects must have identified caregivers/informants
  8. Subjects must provide written informed consent

Key Exclusion criteria:

  1. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD
  2. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
  3. Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
  4. Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator, ferromagnetic metal implants, e,g., in skull and cardiac devices other than those approved as safe for use in MR scanners
  5. 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
  6. A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated electrocardiogram (ECG)
  7. Certain other specified medical conditions
  8. Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767311

Contacts
Contact: Eisai Medical Services (888) 422-4743

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, Arizona
Recruiting
Phoenix, Arizona, United States
Recruiting
Tucson, Arizona, United States
United States, California
Recruiting
Lomita, California, United States
Recruiting
Long Beach, California, United States
Recruiting
Los Alamitos, California, United States
Recruiting
Oxnard, California, United States
United States, Colorado
Recruiting
Denver, Colorado, United States
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
United States, Florida
Recruiting
Atlantis, Florida, United States
Terminated
Boca Raton, Florida, United States
Recruiting
Bradenton, Florida, United States
Recruiting
Deerfield Beach, Florida, United States
Recruiting
Delray Beach, Florida, United States
Recruiting
Fort Meyers, Florida, United States
Recruiting
Hallandale Beach, Florida, United States
Recruiting
Lake Worth, Florida, United States
Recruiting
Miami, Florida, United States
Recruiting
Miami Springs, Florida, United States
Recruiting
Ocala, Florida, United States
Recruiting
Orlando, Florida, United States
Recruiting
Palm Beach Gardens, Florida, United States
Recruiting
Sunrise, Florida, United States
Terminated
Tampa, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Georgia
Recruiting
Atlanta, Georgia, United States
Terminated
Atlanta, Georgia, United States
Recruiting
Columbus, Georgia, United States
Recruiting
Decatur, Georgia, United States
United States, Illinois
Recruiting
Elk Grove Village, Illinois, United States
United States, Indiana
Recruiting
Elkhart, Indiana, United States
Recruiting
Indianapolis, Indiana, United States
United States, Kansas
Recruiting
Wichita, Kansas, United States
United States, Kentucky
Recruiting
Lexington, Kentucky, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
Recruiting
Burlington, Massachusetts, United States
Terminated
Newton, Massachusetts, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
Recruiting
Farmington Hills, Michigan, United States
Recruiting
Lansing, Michigan, United States
Terminated
West Bloomfield, Michigan, United States
United States, New Jersey
Terminated
Eatontown, New Jersey, United States
Recruiting
Toms River, New Jersey, United States
United States, New York
Recruiting
Albany, New York, United States
Recruiting
Amherst, New York, United States
Recruiting
Latham, New York, United States
Recruiting
New York, New York, United States
Recruiting
Rochester, New York, United States
United States, Ohio
Recruiting
Centerville, Ohio, United States
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Abington, Pennsylvania, United States
Recruiting
Jenkintown, Pennsylvania, United States
United States, Rhode Island
Recruiting
East Providence, Rhode Island, United States
United States, Tennessee
Recruiting
Knoxville, Tennessee, United States
United States, Texas
Recruiting
Austin, Texas, United States
Recruiting
Dallas, Texas, United States
Active, not recruiting
Houston, Texas, United States
Terminated
San Antonio, Texas, United States
Recruiting
San Antonio, Texas, United States
United States, Vermont
Recruiting
Bennington, Vermont, United States
United States, Virginia
Recruiting
Richmond, Virginia, United States
United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Chad Swanson Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01767311     History of Changes
Other Study ID Numbers: BAN2401-G000-201
Study First Received: January 8, 2013
Last Updated: August 14, 2014
Health Authority: Italy: The Italian Medicines Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014