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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.
Information provided by (Responsible Party):
Eisai Inc. Identifier:
First received: January 8, 2013
Last updated: February 27, 2017
Last verified: February 2017
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: 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: September 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


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01767311

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
Carson, California, United States
Lomita, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Orange, California, United States
Oxnard, California, United States
San Diego, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Atlantis, Florida, United States
Bradenton, Florida, United States
Deerfield Beach, Florida, United States
Delray Beach, Florida, United States
Fort Meyers, Florida, United States
Hialeah, Florida, United States
Lake Worth, Florida, United States
Leesburg, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Palm Beach Gardens, Florida, United States
Sunrise, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
United States, Indiana
Elkhart, Indiana, United States
Indianapolis, Indiana, United States
United States, Kansas
Wichita, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Massachusetts
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Farmington Hills, Michigan, United States
Lansing, Michigan, United States
United States, New Jersey
Eatontown, New Jersey, United States
Toms River, New Jersey, United States
United States, New York
Albany, New York, United States
Amherst, New York, United States
Latham, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Ohio
Centerville, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Abington, Pennsylvania, United States
United States, Rhode Island
East Providence, Rhode Island, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Vermont
Bennington, Vermont, United States
United States, Virginia
Richmond, Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Canada, Ontario
London, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Paris cedex 10, Paris, France
Guenzburg, Baden Wuerttemberg, Germany
Berlin, Germany
Brescia, Italy
Genova, Italy
Milano, Italy
Pisa, Italy
Roma, Italy
Otake, Hiroshima, Japan
Himeji, Hyogo, Japan
Kobe, Hyogo, Japan
Nishinomiya, Hyogo, Japan
Kyoto-shi, Kyoto, Japan
Kurashiki, Okayama, Japan
Itabashi-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku, Tokyo, Japan
Osaka, Japan
Saitama, Japan
Korea, Republic of
Seongnam-si, Gyeonggi-do, Korea, Republic of
Busan, Gyeongsangnam-do, Korea, Republic of
Seoul, Korea, Republic of
Amsterdam, Netherlands
Sant Cugat del Valles, Barcelona, Spain
San Sebastian, Guipuzcoa, Spain
Barcelona, Spain
Madrid, Spain
Sevilla, Spain
Malmö, Sweden
Mölndal, Sweden
Uppsala, Sweden
United Kingdom
Glasgow, Renfrewshire, United Kingdom
Sponsors and Collaborators
Eisai Inc.
Study Director: Chad Swanson, PhD Eisai Inc.
  More Information

Responsible Party: Eisai Inc. Identifier: NCT01767311     History of Changes
Other Study ID Numbers: BAN2401-G000-201
Study First Received: January 8, 2013
Last Updated: February 27, 2017

Keywords provided by Eisai Inc.:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on May 25, 2017