Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 June 2016 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01767311
First received: January 8, 2013
Last updated: June 6, 2016
Last verified: June 2016
  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
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 ADCOMS at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ 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: July 2018
Estimated Primary Completion Date: June 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

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

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 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
Carson, California, United States
Recruiting
Lomita, California, United States
Recruiting
Long Beach, California, United States
Recruiting
Los Alamitos, California, United States
Withdrawn
Los Angeles, California, United States
Recruiting
Los Angeles, California, United States
Recruiting
Orange, California, United States
Recruiting
Oxnard, California, United States
Recruiting
San Diego, California, United States
United States, Colorado
Terminated
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
Terminated
Hallandale Beach, Florida, United States
Recruiting
Hialeah, Florida, United States
Recruiting
Lake Worth, Florida, United States
Recruiting
Leesburg, Florida, United States
Terminated
Miami Springs, Florida, United States
Recruiting
Miami, Florida, United States
Recruiting
Ocala, Florida, United States
Recruiting
Orlando, Florida, United States
Recruiting
Palm Beach Gardens, Florida, United States
Withdrawn
St. Petersburg, Florida, United States
Recruiting
Sunrise, Florida, United States
Terminated
Tampa, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Georgia
Terminated
Atlanta, Georgia, United States
Recruiting
Atlanta, Georgia, United States
Recruiting
Columbus, Georgia, United States
Recruiting
Decatur, Georgia, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
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
Terminated
Latham, New York, United States
Recruiting
New York, New York, United States
Terminated
New York, New York, United States
Recruiting
Rochester, New York, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
United States, Ohio
Recruiting
Centerville, Ohio, United States
United States, Oklahoma
Terminated
Oklahoma City, Oklahoma, United States
Recruiting
Oklahoma City, Oklahoma, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Abington, Pennsylvania, United States
Terminated
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
Recruiting
Houston, Texas, United States
Recruiting
San Antonio, Texas, United States
Terminated
San Antonio, Texas, United States
United States, Vermont
Recruiting
Bennington, Vermont, United States
United States, Virginia
Active, not recruiting
Richmond, Virginia, United States
United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States
Canada, Ontario
Recruiting
London, Ontario, Canada
Terminated
Ottawa, Ontario, Canada
Recruiting
Peterborough, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Recruiting
Greenfield Park, Quebec, Canada
Recruiting
Montreal, Quebec, Canada
Germany
Recruiting
Guenzburg, Baden Wuerttemberg, Germany
Recruiting
Karlstadt/Main, Bayern, Germany
Withdrawn
Muenchen, Bayern, Germany
Recruiting
Hoppegarten, Berlin, Germany
Recruiting
Hannover, Niedersachsen, Germany
Recruiting
Mittweida, Sachsen, Germany
Recruiting
Berlin, Germany
Not yet recruiting
Hamburg, Germany
Italy
Recruiting
Brescia, Italy
Recruiting
Genova, Italy
Recruiting
Milano, Italy
Recruiting
Pisa, Italy
Recruiting
Roma, Italy
Recruiting
Sevilla, Italy
Japan
Not yet recruiting
Fukuoka-shi, Fukuoka, Japan
Recruiting
Otake, Hiroshima, Japan
Recruiting
Himeji, Hyogo, Japan
Not yet recruiting
Himeji, Hyogo, Japan
Recruiting
Kobe, Hyogo, Japan
Recruiting
Nishinomiya, Hyogo, Japan
Recruiting
Kyoto-shi, Kyoto, Japan
Recruiting
Kurashiki, Okayama, Japan
Not yet recruiting
Suita, Osaka, Japan
Recruiting
Shinjuku, Tokoyo, Japan
Not yet recruiting
Itabashi-ku, Tokyo, Japan
Recruiting
Shinjuku-ku, Tokyo, Japan
Recruiting
Osaka, Japan
Not yet recruiting
Osaka, Japan
Recruiting
Saitama, Japan
Korea, Republic of
Active, not recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of
Active, not recruiting
Seoul, Gyeonggi-do, Korea, Republic of
Recruiting
Busan, Gyeongsangnam-do, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Spain
Recruiting
Sant Cugat del Valles, Barcelona, Spain
Recruiting
San Sebastian, Guipuzcoa, Spain
Recruiting
Barakaldo, Vizcaya, Spain
Active, not recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
Sweden
Recruiting
Malmö, Sweden
Recruiting
Mölndal, Sweden
Recruiting
Uppsala, Sweden
United Kingdom
Active, not recruiting
Glasgow, Renfrewshire, United Kingdom
Not yet recruiting
Swindon, Wiltshire, 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 
Study First Received: January 8, 2013
Last Updated: June 6, 2016
Health Authority: Italy: The Italian Medicines Agency
United States: Food and Drug Administration
France: French National Agency for Medicines and Health Products Safety
Germany: Paul-Ehrlich-Institut
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Medicines Regulatory Authority
Spain: The Spanish Agency of Medicines and Medical Devices
Canada: Health Canada

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

ClinicalTrials.gov processed this record on December 09, 2016