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

This study is currently recruiting participants.
Verified October 2013 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01767311
First received: January 8, 2013
Last updated: October 17, 2013
Last verified: October 2013
  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
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
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States
Principal Investigator: David Gelmacher         
United States, Arizona
Xenoscience Inc. Recruiting
Phoenix, Arizona, United States
Principal Investigator: Stephen Flitman         
University of Arizona Recruiting
Tucson, Arizona, United States
Principal Investigator: Geoffrey Ahern         
United States, California
Torrance Clin Res Ins Inc. Recruiting
Lomita, California, United States
Principal Investigator: Marina Raikhel         
Collaborative Neuro Network Recruiting
Long Beach, California, United States
Principal Investigator: Omid Omidvar         
Pharmacology Res Institute Recruiting
Los Alamitos, California, United States
Principal Investigator: Nader Oskooilar         
Pacific Neurosc Med Grp Neu Recruiting
Oxnard, California, United States
Principal Investigator: James Sutton         
United States, Colorado
Radiant Research Inc. Recruiting
Denver, Colorado, United States
Principal Investigator: John DeQuardo         
United States, Connecticut
Inst for Neurodege Disorders Recruiting
New Haven, Connecticut, United States
Principal Investigator: Danna Jennings         
Inv Drug Services Recruiting
New Haven, Connecticut, United States
Principal Investigator: Christopher Van Dyck         
United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States
Principal Investigator: Mark Goldstein         
Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States
Principal Investigator: Stuart Isaacson         
Florida Atlantic Univ Charles Recruiting
Boca Raton, Florida, United States
Principal Investigator: Peter Holland         
Bradenton Res Center Inc. Recruiting
Bradenton, Florida, United States
Principal Investigator: William McElveen         
Quatum Laboratories Inc. Recruiting
Deerfield Beach, Florida, United States
Principal Investigator: Jose De La Gandara         
Brain Matters Research Inc. Recruiting
Delray Beach, Florida, United States
Principal Investigator: Mark Brody         
Internal Medicine Assoc Recruiting
Fort Meyers, Florida, United States
Principal Investigator: Frederick Schaerf         
MD Clinical Recruiting
Hallandale Beach, Florida, United States
Principal Investigator: Beth Safirstein         
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States
Principal Investigator: Watson         
Miami Jewish Health System Recruiting
Miami, Florida, United States
Principal Investigator: Marc Agronin         
Galiz Research LLC Recruiting
Miami Springs, Florida, United States
Principal Investigator: Jose Gamez         
Renstar Medical Research Recruiting
Ocala, Florida, United States
Principal Investigator: John Nardandrea         
Compass Research LLC Recruiting
Orlando, Florida, United States
Principal Investigator: Craig Curtis         
Palm Beach Neurological Center Recruiting
Palm Beach Gardens, Florida, United States
Principal Investigator: Michael Tuchman         
Neu Clinical Research Inc. Recruiting
Sunrise, Florida, United States
Principal Investigator: Richard Singer         
USF Health Byrd Institute Recruiting
Tampa, Florida, United States
Principal Investigator: Amanda Smith         
Stedman Clin Trials LLC Res Recruiting
Tampa, Florida, United States
Principal Investigator: Mary Stedman         
Axiom Clin Res of Florida Recruiting
Tampa, Florida, United States
Principal Investigator: Susan Steen         
United States, Georgia
Atlanta Cen for Med Research Recruiting
Atlanta, Georgia, United States
Principal Investigator: Robert Riesenberg         
Wesley Woods Outpatient Clinic Recruiting
Atlanta, Georgia, United States
Principal Investigator: Allan Levey         
Columbus Regional Med Cent Recruiting
Columbus, Georgia, United States
Principal Investigator: Jonathan Liss         
NeuroStudies.net LLC Recruiting
Decatur, Georgia, United States
Principal Investigator: Marshall Nash         
United States, Illinois
Alexian Bro Neuro Ins Recruiting
Elk Grove Village, Illinois, United States
Principal Investigator: Concetta Forchetti         
United States, Indiana
Indiana Medical Research Recruiting
Elkhart, Indiana, United States
Principal Investigator: Thomas Vidic         
Inv Drug Services Recruiting
Indianapolis, Indiana, United States
Principal Investigator: Martin Farlow         
United States, Kansas
University of Kansas School of Medicine at Wichita Recruiting
Wichita, Kansas, United States
Principal Investigator: Joel Ross         
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States
Principal Investigator: Gregory Jicha         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States
Principal Investigator: Gad Marshall         
Boston University Alzheimer's Disease Center Recruiting
Boston, Massachusetts, United States
Principal Investigator: Robert Stern         
Lahey Clinic Inc. Recruiting
Burlington, Massachusetts, United States
Principal Investigator: Yuval Zabar         
Neurocare Inc. Recruiting
Newton, Massachusetts, United States
Principal Investigator: Michael Biber         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States
Principal Investigator: Nancy Barbas         
Quest Res Inst Recruiting
Farmington Hills, Michigan, United States
Principal Investigator: Aaron Ellenbogen         
Michigan State university, Dept of Neurology Recruiting
Lansing, Michigan, United States
Principal Investigator: Andrea Bozoki         
Henry Ford Health System Recruiting
West Bloomfield, Michigan, United States
Principal Investigator: Rhonna Shatz         
United States, New Jersey
Memory Enhancement Center Terminated
Eatontown, New Jersey, United States
Memory Enhancement Cent Recruiting
Toms River, New Jersey, United States
Principal Investigator: Sanjiv Sharma         
United States, New York
The Neurology Group; LLP Recruiting
Albany, New York, United States
Principal Investigator: David Hart         
Dent Neurologic Institute Recruiting
Amherst, New York, United States
Principal Investigator: Horacio Capote         
Fallon Wellness Pharmacy Recruiting
Latham, New York, United States
Principal Investigator: Keith Edwards         
NYU Langone Medical Center Not yet recruiting
New York, New York, United States
Principal Investigator: Martin Sadowski         
Weill Cornell Memory Disorders Program Recruiting
New York, New York, United States
Principal Investigator: Norman Relkin         
University of Rochester Medical Center Recruiting
Rochester, New York, United States
Principal Investigator: Anton Porteinsson         
Psy and Alz Care of Rochester Recruiting
Rochester, New York, United States
Principal Investigator: Saleem Ismail         
United States, Ohio
Valley Medical Primary Care Recruiting
Centerville, Ohio, United States
Principal Investigator: Meenakshi Patel         
United States, Oklahoma
Lynn Heal Scie Ins Office Recruiting
Oklahoma City, Oklahoma, United States
Principal Investigator: Mark Fisher         
United States, Oregon
Summit Research Network Recruiting
Portland, Oregon, United States
Principal Investigator: Scott Losk         
Oregon Health and Science University Recruiting
Portland, Oregon, United States
Principal Investigator: Joseph Quinn         
United States, Pennsylvania
Abington Memorial Hosp Recruiting
Abington, Pennsylvania, United States
Principal Investigator: David Weisman         
Clinical Trial Center LLC Recruiting
Jenkintown, Pennsylvania, United States
Principal Investigator: Marvin Kalafer         
United States, Rhode Island
Rhode Is Mood and Mem Res Recruiting
East Providence, Rhode Island, United States
Principal Investigator: John Stoukides         
United States, Tennessee
New Orleans Cnt Clin Res Recruiting
Knoxville, Tennessee, United States
Principal Investigator: William Smith         
United States, Texas
Sr Adult Specialty Research Recruiting
Austin, Texas, United States
Principal Investigator: Jaron Winston         
FutureSearch Trials of Dallas Recruiting
Dallas, Texas, United States
Principal Investigator: Michael Downing         
Clinical Trial Network Active, not recruiting
Houston, Texas, United States
FORU Recruiting
San Antonio, Texas, United States
Principal Investigator: Donald Royall         
Innovative Clinical Trials Recruiting
San Antonio, Texas, United States
Principal Investigator: James Garrison         
United States, Vermont
The Pharmacy; Inc. Recruiting
Bennington, Vermont, United States
Principal Investigator: Cynthia Murphy         
United States, Virginia
National Clinical Research Inc Recruiting
Richmond, Virginia, United States
Principal Investigator: John Hoekstra         
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States
Principal Investigator: Piero Antuono         
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: October 17, 2013
Health Authority: Italy: The Italian Medicines Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014