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 Marker CityStateStatusPrimary Contact

Geolocation is 33.5206608, -86.80249

n/a
Birmingham
Alabama
Recruiting
n/a

Geolocation is 33.4483771, -112.0740373

n/a
Phoenix
Arizona
Recruiting
n/a

Geolocation is 32.2217429, -110.926479

n/a
Tucson
Arizona
Recruiting
n/a

Geolocation is 33.8316745, -118.281693

n/a
Carson
California
Recruiting
n/a

Geolocation is 33.7922392, -118.3150722

n/a
Lomita
California
Recruiting
n/a

Geolocation is 33.7700504, -118.1937395

n/a
Long Beach
California
Recruiting
n/a

Geolocation is 33.8030716, -118.0725641

n/a
Los Alamitos
California
Recruiting
n/a

Geolocation is 34.0522342, -118.2436849

n/a
Los Angeles
California
Withdrawn
n/a

Geolocation is 34.0522342, -118.2436849

n/a
Los Angeles
California
Recruiting
n/a

Geolocation is 33.7877944, -117.8531119

n/a
Orange
California
Recruiting
n/a

Geolocation is 34.1975048, -119.1770516

n/a
Oxnard
California
Recruiting
n/a

Geolocation is 32.715738, -117.1610838

n/a
San Diego
California
Recruiting
n/a

Geolocation is 39.7392358, -104.990251

n/a
Denver
Colorado
Terminated
n/a

Geolocation is 41.308274, -72.9278835

n/a
New Haven
Connecticut
Recruiting
n/a

Geolocation is 26.5909025, -80.1008762

n/a
Atlantis
Florida
Recruiting
n/a

Geolocation is 26.3683064, -80.1289321

n/a
Boca Raton
Florida
Terminated
n/a

Geolocation is 27.4989278, -82.5748194

n/a
Bradenton
Florida
Recruiting
n/a

Geolocation is 26.3184123, -80.0997657

n/a
Deerfield Beach
Florida
Recruiting
n/a

Geolocation is 26.4614625, -80.0728201

n/a
Delray Beach
Florida
Recruiting
n/a

Geolocation is 26.640628, -81.8723084

n/a
Fort Meyers
Florida
Recruiting
n/a

Geolocation is 25.9812024, -80.148379

n/a
Hallandale Beach
Florida
Terminated
n/a

Geolocation is 25.8575963, -80.2781057

n/a
Hialeah
Florida
Recruiting
n/a

Geolocation is 26.6167555, -80.0684479

n/a
Lake Worth
Florida
Recruiting
n/a

Geolocation is 28.810823, -81.8778582

n/a
Leesburg
Florida
Recruiting
n/a

Geolocation is 25.8223198, -80.289495

n/a
Miami Springs
Florida
Terminated
n/a

Geolocation is 25.7616798, -80.1917902

n/a
Miami
Florida
Recruiting
n/a

Geolocation is 29.1871986, -82.1400923

n/a
Ocala
Florida
Recruiting
n/a

Geolocation is 28.5383355, -81.3792365

n/a
Orlando
Florida
Recruiting
n/a

Geolocation is 26.8233946, -80.1386547

n/a
Palm Beach Gardens
Florida
Recruiting
n/a

Geolocation is 27.7518284, -82.6267345

n/a
St. Petersburg
Florida
Withdrawn
n/a

Geolocation is 26.1669711, -80.256595

n/a
Sunrise
Florida
Recruiting
n/a

Geolocation is 27.950575, -82.4571776

n/a
Tampa
Florida
Terminated
n/a

Geolocation is 27.950575, -82.4571776

n/a
Tampa
Florida
Recruiting
n/a

Geolocation is 33.7489954, -84.3879824

n/a
Atlanta
Georgia
Terminated
n/a

Geolocation is 33.7489954, -84.3879824

n/a
Atlanta
Georgia
Recruiting
n/a

Geolocation is 32.4609764, -84.9877094

n/a
Columbus
Georgia
Recruiting
n/a

Geolocation is 33.7748275, -84.2963123

n/a
Decatur
Georgia
Recruiting
n/a

Geolocation is 41.8781136, -87.6297982

n/a
Chicago
Illinois
Recruiting
n/a

Geolocation is 42.0039178, -87.9703461

n/a
Elk Grove Village
Illinois
Recruiting
n/a

Geolocation is 41.6819935, -85.9766671

n/a
Elkhart
Indiana
Recruiting
n/a

Geolocation is 39.768403, -86.158068

n/a
Indianapolis
Indiana
Recruiting
n/a

Geolocation is 37.6871761, -97.330053

n/a
Wichita
Kansas
Recruiting
n/a

Geolocation is 38.0405837, -84.5037164

n/a
Lexington
Kentucky
Recruiting
n/a

Geolocation is 42.3600825, -71.0588801

n/a
Boston
Massachusetts
Recruiting
n/a

Geolocation is 42.5047161, -71.1956205

n/a
Burlington
Massachusetts
Recruiting
n/a

Geolocation is 42.3370413, -71.2092214

n/a
Newton
Massachusetts
Terminated
n/a

Geolocation is 42.2808256, -83.7430378

n/a
Ann Arbor
Michigan
Recruiting
n/a

Geolocation is 42.4989936, -83.3677168

n/a
Farmington Hills
Michigan
Recruiting
n/a

Geolocation is 42.732535, -84.5555347

n/a
Lansing
Michigan
Recruiting
n/a

Geolocation is 42.5678534, -83.373339

n/a
West Bloomfield
Michigan
Terminated
n/a

Geolocation is 40.2962222, -74.0509725

n/a
Eatontown
New Jersey
Terminated
n/a

Geolocation is 39.9537358, -74.1979458

n/a
Toms River
New Jersey
Recruiting
n/a

Geolocation is 42.6525793, -73.7562317

n/a
Albany
New York
Recruiting
n/a

Geolocation is 42.9756133, -78.7914222

n/a
Amherst
New York
Recruiting
n/a

Geolocation is 42.7477661, -73.760537

n/a
Latham
New York
Terminated
n/a

Geolocation is 40.7127837, -74.0059413

n/a
New York
New York
Recruiting
n/a

Geolocation is 40.7127837, -74.0059413

n/a
New York
New York
Terminated
n/a

Geolocation is 43.16103, -77.6109219

n/a
Rochester
New York
Recruiting
n/a

Geolocation is 35.2270869, -80.8431267

n/a
Charlotte
North Carolina
Recruiting
n/a

Geolocation is 39.6283928, -84.1593818

n/a
Centerville
Ohio
Recruiting
n/a

Geolocation is 35.4675602, -97.5164276

n/a
Oklahoma City
Oklahoma
Terminated
n/a

Geolocation is 35.4675602, -97.5164276

n/a
Oklahoma City
Oklahoma
Recruiting
n/a

Geolocation is 45.5230622, -122.6764816

n/a
Portland
Oregon
Recruiting
n/a

Geolocation is 40.1198332, -75.1253492

n/a
Abington
Pennsylvania
Recruiting
n/a

Geolocation is 40.0959438, -75.1251743

n/a
Jenkintown
Pennsylvania
Terminated
n/a

Geolocation is 41.8137116, -71.3700545

n/a
East Providence
Rhode Island
Recruiting
n/a

Geolocation is 35.9606384, -83.9207392

n/a
Knoxville
Tennessee
Recruiting
n/a

Geolocation is 30.267153, -97.7430608

n/a
Austin
Texas
Recruiting
n/a

Geolocation is 32.7766642, -96.7969879

n/a
Dallas
Texas
Recruiting
n/a

Geolocation is 29.7604267, -95.3698028

n/a
Houston
Texas
Recruiting
n/a

Geolocation is 29.4241219, -98.4936282

n/a
San Antonio
Texas
Recruiting
n/a

Geolocation is 29.4241219, -98.4936282

n/a
San Antonio
Texas
Terminated
n/a

Geolocation is 42.8781345, -73.1967741

n/a
Bennington
Vermont
Recruiting
n/a

Geolocation is 37.5407246, -77.4360481

n/a
Richmond
Virginia
Active, not recruiting
n/a

Geolocation is 43.0389025, -87.9064736

n/a
Milwaukee
Wisconsin
Recruiting
n/a

Geolocation is 42.9869502, -81.243177

n/a
London
Ontario
Recruiting
n/a

Geolocation is 45.4215296, -75.6971931

n/a
Ottawa
Ontario
Terminated
n/a

Geolocation is 44.309058, -78.319747

n/a
Peterborough
Ontario
Recruiting
n/a

Geolocation is 43.653226, -79.3831843

n/a
Toronto
Ontario
Recruiting
n/a

Geolocation is 45.4853584, -73.4786541

n/a
Greenfield Park
Quebec
Recruiting
n/a

Geolocation is 45.5016889, -73.567256

n/a
Montreal
Quebec
Recruiting
n/a
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