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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767311
First Posted: January 14, 2013
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  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 (ADCOMS). 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 participants and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of participants. Participants 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ADCOMS at 12 months [ Time Frame: Baseline and 12 months ]
  • Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From the time the participant signs the informed consent form until 3 months after the last dose of study drug or through the last visit, whichever is longer ]
    Safety assessments will consist of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and ECGs; Safety MRI; and performance of physical examinations.


Secondary Outcome Measures:
  • Change from baseline in the ADCOMS at 18 months [ Time Frame: Baseline and 18 months ]
  • 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 ]
  • 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 ]

Enrollment: 856
Actual Study Start Date: December 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: July 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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. 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
  2. Positive amyloid load as indicated by PET or CSF assessment
  3. Age between 50 and 90 years, inclusive
  4. Mini Mental State Examination (MMSE) score equal to or greater than 22, and equal to or less than 30, at Screening and Baseline
  5. Body Mass Index (BMI) greater than 17 and less than 35 at Screening
  6. Females must not be pregnant or lactating, and specified contraceptive precautions must be followed
  7. 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
  8. Subjects must have identified caregivers/informants
  9. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767311


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, Arizona
Xenoscience Inc.
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
United States, California
American Neuropsychiatric Research Institute Inc
Carson, California, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
The Regents Of The University Of California
Orange, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
United States, Colorado
Radiant Research, Inc.
Denver, Colorado, United States
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
United States, Florida
JEM Research Institute
Atlantis, Florida, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Quantum Laboratories Inc.
Deerfield Beach, Florida, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Berma Research Group
Hialeah, Florida, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States
Galiz Research, LLC
Miami Springs, Florida, United States
CCM Clinical Research Group, Inc.
Miami, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Misael Gonzalez, MD
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research Main
Orlando, Florida, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
USF Suncoast Gerontology Center
Tampa, Florida, United States
Compass Research, LLC
The Villages, Florida, United States
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Emory University Cognitive Neurology Clinic & ADRC
Atlanta, Georgia, United States
Columbus Regional Medical Center
Columbus, Georgia, United States
NeuroStudies.net, LLC
Decatur, Georgia, United States
United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, United States
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
United States, Kansas
University of Kansas Medical Center Research Institute, Inc. - Master
Wichita, Kansas, United States
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Clinic Inc. - PARENT ACCOUNT
Burlington, Massachusetts, United States
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Advanced Memory Research Institute of NJ, PC
Toms River, New Jersey, United States
United States, New York
The Neurology Group, LLP
Albany, New York, United States
Dent Neurologic Institute
Amherst, New York, United States
Empire Neurology, PC
Latham, New York, United States
Weill Cornell Medical College New York Presbyterian Hospital
New York, New York, United States
Psychiatry and Alzheimer's Care of Rochester. PLLC
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
United States, North Carolina
ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
Charlotte, North Carolina, United States
United States, Ohio
Valley Medical Primary Care
Centerville, Ohio, United States
United States, Oklahoma
Cutting Edge Research Group, Inc.
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
United States, Pennsylvania
Abington Neurological Associates
Abington, Pennsylvania, United States
United States, Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
United States, Texas
Senior Adult Specialty Research
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Texas Neurology, PA
Dallas, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States
United States, Virginia
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States
United States, Wisconsin
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
Canada, Ontario
Saint Joseph's HC- Parkwood Institute
London, Ontario, Canada
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, Ontario, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada
Canada, Quebec
Neuro Rive Sud Clinic/Center for Diagnosis & Research on Alzheimer's Disease
Greenfield Park, Quebec, Canada
Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Ile-de-Montreal
Montreal, Quebec, Canada
France
Hopital Lariboisiere
Paris cedex 10, Paris, France
Germany
Bezirkskrankenhaus Gunzburg
Gunzburg, Baden Wuerttemberg, Germany
Praxis Dr. med. Peter Franz
Berlin, Germany
Praxis Dr. med. Volker Schumann
Berlin, Germany
Italy
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Fondazione Santa Lucia IRCCS
Roma, Italy
Umberto I Pol. di Roma-Universita di Roma La Sapienza
Roma, Italy
Japan
NHO Hiroshima-Nishi Medical Center
Otake-shi, Hiroshima-Ken, Japan
Himeji Central Hospital Clinic
Himeji-shi, Hyogo-Ken, Japan
Hyogo Brain and Heart Center
Himeji-shi, Hyogo-Ken, Japan
Saneikai Tsukazaki Hospital
Himeji-shi, Hyogo-Ken, Japan
Kobe University Hospital
Kobe-shi, Hyogo-Ken, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi, Hyogo-Ken, Japan
Ishikawa Clinic
Kyoto-shi, Kyoto-Fu, Japan
Katayama Medical Clinic
Kurashiki-shi, Okayama-Ken, Japan
Kotobukikai Tominaga Hopital
Osaka-shi, Osaka-Fu, Japan
Synapse Saitama Neuropsychiatry Center
Saitama-shi, Saitama-Ken, Japan
Tokyo Metropolitan Geriatric Hospital
Itabashi-ku, Tokyo-To, Japan
Shinjuku Research Park Clinic
Shinjuku-ku, Tokyo-To, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo-To, Japan
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Dong-A University Hospital
Busan, Gyeongsangnam-do, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of
Netherlands
Alzheimer Research Center
Amsterdam, Netherlands
Spain
Hospital General de Catalunya
Sant Cugat del Valles, Barcelona, Spain
Policlinica Guipuzcoa
San Sebastian, Guipuzcoa, Spain
Fundacio ACE
Barcelona, Spain
Hospital de Cantoblanco
Madrid, Spain
Hospital Universitario Clinico San Carlos
Madrid, Spain
Hospital Universitario Virgen Macarena
Sevilla, Spain
Sweden
Skanes Universitetssjukhus, Malmo
Malmo, Sweden
Sahlgrenska Universitetssjukhuset, Molndal Sjukhus
Molndal, Sweden
Akademiska Sjukhuset
Uppsala, Sweden
United Kingdom
Glasgow Memory Clinic Ltd
Glasgow, Renfrewshire, United Kingdom
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Chad Swanson, PhD Eisai Inc.
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01767311     History of Changes
Other Study ID Numbers: BAN2401-G000-201
First Submitted: January 8, 2013
First Posted: January 14, 2013
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Eisai Inc.:
Alzheimer's Disease
BAN2401

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders