Alzheimer's Disease Education and Referral Center

BAN2401 for Early Alzheimer's Disease

BAN2401 for Early Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

This study will test the effectiveness of the experimental drug BAN2401 as a possible treatment for people with mild cognitive impairment (MCI) or mild Alzheimer's disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
90 Years
Both
No
Inclusion Criteria: 

    All Participants

    • Positive amyloid load as indicated by PET brain scan
    • MMSE score of 22-30 inclusive at screening and beginning of trial
    • Body mass index of less than 35
    • Women must not be pregnant or lactating, and specified contraceptive precautions must be followed.
    • If taking acetylcholinesterase inhibitor or memantine, must be on a stable dose for at least 12 weeks
    • Available, identified caregiver

    Participants with Mild Cognitive Impairment due to Alzheimer's

    • Intermediate likelihood of MCI according to National Institute of Aging-Alzheimer's Association (NIA-AA) core clinical criteria
    • Clinical Dementia Rating score of 0.5; Memory Box score of 0.5 or greater
    • History of subjective memory decline, with gradual onset and slow progression during the year before screening, corroborated by a family member or friend
    • Objective impairment in episodic memory, as indicated by the Wechsler Memory Scale, 4th edition

    Participants with Mild Alzheimer's Dementia

    • Probable Alzheimer's dementia according to NIA-AA core clinical criteria
    • Clinical Dementia Rating score of 0.5-1.0; Memory Box score of 0.5 or greater  
Exclusion Criteria: 
    • Any neurological condition besides Alzheimer's disease that may be contributing to cognitive impairment
    • History of transient ischemic attack (TIA), stroke, or seizure within 12 months of screening
    • Any psychiatric diagnosis or symptoms (for example, hallucinations, major depression, or delusions) that could interfere with study procedures
    • Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator or magnetic metal implants
    • MRI evidence of clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's disease or other significant pathological findings
    • Prolonged QT/QTc interval (QTc > 450 ms) as shown by a repeated electrocardiogram (ECG)
    • Severe visual or hearing impairment that would prevent accurate performance on psychometric tests
Detailed Description: 

This 18-month, Phase II study will test the effectiveness of the experimental drug BAN2401 as a possible treatment for people with mild cognitive impairment (MCI) or mild Alzheimer's disease. BAN2401 is a monoclonal antibody that binds to large oligomers, called protofibrils, and neutralizes their damage to brain cells. Five different dose levels will be tested, including three different doses (2.5, 5, and 10 mg/kg) given every 2 weeks and two different doses (5 and 10 mg/kg) given monthly. During the study, frequent interim analyses will be conducted to guide subsequent randomization of participants into dose groups.

Central Contact Information: 

For more information about this study or study locations, contact Eisai Medical Services at 1-888-422-4743.

 

Locations: 
Map MarkerCityStateStatus

Geolocation is 33.5206608, -86.80249

Birmingham
Alabama
Recruiting

Geolocation is 33.4483771, -112.0740373

Phoenix
Arizona
Recruiting

Geolocation is 32.2217429, -110.926479

Tucson
Arizona
Recruiting

Geolocation is 33.8316745, -118.281693

Carson
California
Recruiting

Geolocation is 33.7922392, -118.3150722

Lomita
California
Recruiting

Geolocation is 33.7700504, -118.1937395

Long Beach
California
Recruiting

Geolocation is 33.8030716, -118.0725641

Los Alamitos
California
Recruiting

Geolocation is 34.0522342, -118.2436849

Los Angeles
California
Recruiting

Geolocation is 34.1975048, -119.1770516

Oxnard
California
Recruiting

Geolocation is 32.715738, -117.1610838

San Diego
California
Recruiting

Geolocation is 39.7392358, -104.990251

Denver
Colorado
Terminated

Geolocation is 41.308274, -72.9278835

New Haven
Connecticut
Recruiting

Geolocation is 26.5909025, -80.1008762

Atlantis
Florida
Recruiting

Geolocation is 26.3683064, -80.1289321

Boca Raton
Florida
Terminated

Geolocation is 27.4989278, -82.5748194

Bradenton
Florida
Recruiting

Geolocation is 26.3184123, -80.0997657

Deerfield Beach
Florida
Recruiting

Geolocation is 26.4614625, -80.0728201

Delray Beach
Florida
Recruiting

Geolocation is 26.640628, -81.8723084

Fort Meyers
Florida
Recruiting

Geolocation is 25.9812024, -80.148379

Hallandale Beach
Florida
Recruiting

Geolocation is 25.8575963, -80.2781057

Hialeah
Florida
Recruiting

Geolocation is 26.6167555, -80.0684479

Lake Worth
Florida
Recruiting

Geolocation is 28.810823, -81.8778582

Leesburg
Florida
Recruiting

Geolocation is 25.8223198, -80.289495

Miami Springs
Florida
Recruiting

Geolocation is 25.7616798, -80.1917902

Miami
Florida
Recruiting

Geolocation is 29.1871986, -82.1400923

Ocala
Florida
Recruiting

Geolocation is 28.5383355, -81.3792365

Orlando
Florida
Recruiting

Geolocation is 26.8233946, -80.1386547

Palm Beach Gardens
Florida
Recruiting

Geolocation is 27.7518284, -82.6267345

St. Petersburg
Florida
Recruiting

Geolocation is 26.1669711, -80.256595

Sunrise
Florida
Recruiting

Geolocation is 27.950575, -82.4571776

Tampa
Florida
Terminated

Geolocation is 27.950575, -82.4571776

Tampa
Florida
Recruiting

Geolocation is 33.7489954, -84.3879824

Atlanta
Georgia
Terminated

Geolocation is 33.7489954, -84.3879824

Atlanta
Georgia
Recruiting

Geolocation is 32.4609764, -84.9877094

Columbus
Georgia
Recruiting

Geolocation is 33.7748275, -84.2963123

Decatur
Georgia
Recruiting

Geolocation is 41.8781136, -87.6297982

Chicago
Illinois
Recruiting

Geolocation is 42.0039178, -87.9703461

Elk Grove Village
Illinois
Recruiting

Geolocation is 41.6819935, -85.9766671

Elkhart
Indiana
Recruiting

Geolocation is 39.768403, -86.158068

Indianapolis
Indiana
Recruiting

Geolocation is 37.6871761, -97.330053

Wichita
Kansas
Recruiting

Geolocation is 38.0405837, -84.5037164

Lexington
Kentucky
Recruiting

Geolocation is 42.3600825, -71.0588801

Boston
Massachusetts
Recruiting

Geolocation is 42.5047161, -71.1956205

Burlington
Massachusetts
Recruiting

Geolocation is 42.3370413, -71.2092214

Newton
Massachusetts
Terminated

Geolocation is 42.2808256, -83.7430378

Ann Arbor
Michigan
Recruiting

Geolocation is 42.4989936, -83.3677168

Farmington Hills
Michigan
Recruiting

Geolocation is 42.732535, -84.5555347

Lansing
Michigan
Recruiting

Geolocation is 42.5678534, -83.373339

West Bloomfield
Michigan
Terminated

Geolocation is 40.2962222, -74.0509725

Eatontown
New Jersey
Terminated

Geolocation is 39.9537358, -74.1979458

Toms River
New Jersey
Recruiting

Geolocation is 42.6525793, -73.7562317

Albany
New York
Recruiting

Geolocation is 42.9756133, -78.7914222

Amherst
New York
Recruiting

Geolocation is 42.7477661, -73.760537

Latham
New York
Recruiting

Geolocation is 40.7127837, -74.0059413

New York
New York
Recruiting

Geolocation is 40.7127837, -74.0059413

New York
New York
Terminated

Geolocation is 43.16103, -77.6109219

Rochester
New York
Recruiting

Geolocation is 39.6283928, -84.1593818

Centerville
Ohio
Recruiting

Geolocation is 35.4675602, -97.5164276

Oklahoma City
Oklahoma
Recruiting

Geolocation is 45.5230622, -122.6764816

Portland
Oregon
Recruiting

Geolocation is 40.1198332, -75.1253492

Abington
Pennsylvania
Recruiting

Geolocation is 40.0959438, -75.1251743

Jenkintown
Pennsylvania
Terminated

Geolocation is 41.8137116, -71.3700545

East Providence
Rhode Island
Recruiting

Geolocation is 35.9606384, -83.9207392

Knoxville
Tennessee
Recruiting

Geolocation is 30.267153, -97.7430608

Austin
Texas
Recruiting

Geolocation is 32.7766642, -96.7969879

Dallas
Texas
Recruiting

Geolocation is 29.7604267, -95.3698028

Houston
Texas
Recruiting

Geolocation is 29.4241219, -98.4936282

San Antonio
Texas
Recruiting

Geolocation is 29.4241219, -98.4936282

San Antonio
Texas
Terminated

Geolocation is 42.8781345, -73.1967741

Bennington
Vermont
Recruiting

Geolocation is 37.5407246, -77.4360481

Richmond
Virginia
Recruiting

Geolocation is 43.0389025, -87.9064736

Milwaukee
Wisconsin
Recruiting
Lead Sponsor: 
Agency
Eisai Inc.
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Chad Swanson
Study Director
Eisai Inc.
Study Contact: 
NamePhone
Eisai Medical Services
888-422-4743
Locations
 
 
ClinicalTrials.gov ID 
NCT01767311 (follow link to view full record on ct.gov in new window)
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
Study Start Date: 
December 2012
Study End Date: 
June 2018
Disease Stage: 
Early
Enrollment: 
800