Alzheimer's Disease Education and Referral Center

BAN2401 for Early Alzheimer's Disease

BAN2401 for Early Alzheimer's Disease

Overall Status: 
Active, not 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 CityStatePrimary Contact

Geolocation is 33.5206608, -86.80249

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Birmingham
Alabama
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Geolocation is 33.4483771, -112.0740373

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Phoenix
Arizona
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Geolocation is 32.2217429, -110.926479

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Tucson
Arizona
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Geolocation is 33.8316745, -118.281693

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Carson
California
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Geolocation is 33.7922392, -118.3150722

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Lomita
California
n/a

Geolocation is 33.7700504, -118.1937395

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Long Beach
California
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Geolocation is 33.8030716, -118.0725641

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Los Alamitos
California
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Geolocation is 33.7877944, -117.8531119

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Orange
California
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Geolocation is 34.1975048, -119.1770516

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Oxnard
California
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Geolocation is 32.715738, -117.1610838

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San Diego
California
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Geolocation is 39.7392358, -104.990251

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Denver
Colorado
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Geolocation is 41.308274, -72.9278835

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New Haven
Connecticut
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Geolocation is 26.5909025, -80.1008762

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Atlantis
Florida
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Geolocation is 27.4989278, -82.5748194

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Bradenton
Florida
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Geolocation is 26.3184123, -80.0997657

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Deerfield Beach
Florida
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Geolocation is 26.4614625, -80.0728201

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Delray Beach
Florida
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Geolocation is 26.640628, -81.8723084

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Fort Meyers
Florida
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Geolocation is 25.8575963, -80.2781057

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Hialeah
Florida
n/a

Geolocation is 26.6167555, -80.0684479

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Lake Worth
Florida
n/a

Geolocation is 28.810823, -81.8778582

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Leesburg
Florida
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Geolocation is 25.8223198, -80.289495

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Miami Springs
Florida
n/a

Geolocation is 25.7616798, -80.1917902

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Miami
Florida
n/a

Geolocation is 29.1871986, -82.1400923

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Ocala
Florida
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Geolocation is 28.5383355, -81.3792365

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Orlando
Florida
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Geolocation is 26.8233946, -80.1386547

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Palm Beach Gardens
Florida
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Geolocation is 26.1669711, -80.256595

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Sunrise
Florida
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Geolocation is 27.950575, -82.4571776

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Tampa
Florida
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Geolocation is 33.7489954, -84.3879824

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Atlanta
Georgia
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Geolocation is 32.4609764, -84.9877094

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Columbus
Georgia
n/a

Geolocation is 33.7748275, -84.2963123

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Decatur
Georgia
n/a

Geolocation is 41.8781136, -87.6297982

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Chicago
Illinois
n/a

Geolocation is 42.0039178, -87.9703461

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Elk Grove Village
Illinois
n/a

Geolocation is 41.6819935, -85.9766671

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Elkhart
Indiana
n/a

Geolocation is 39.768403, -86.158068

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Indianapolis
Indiana
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Geolocation is 37.6871761, -97.330053

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Wichita
Kansas
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Geolocation is 38.0405837, -84.5037164

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Lexington
Kentucky
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Geolocation is 42.3600825, -71.0588801

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Boston
Massachusetts
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Geolocation is 42.5047161, -71.1956205

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Burlington
Massachusetts
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Geolocation is 42.2808256, -83.7430378

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Ann Arbor
Michigan
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Geolocation is 42.4989936, -83.3677168

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Farmington Hills
Michigan
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Geolocation is 42.732535, -84.5555347

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Lansing
Michigan
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Geolocation is 40.2962222, -74.0509725

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Eatontown
New Jersey
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Geolocation is 39.9537358, -74.1979458

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Toms River
New Jersey
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Geolocation is 42.6525793, -73.7562317

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Albany
New York
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Geolocation is 42.9790067, -78.792272

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Amherst
New York
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Geolocation is 42.7477661, -73.760537

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Latham
New York
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Geolocation is 40.7127837, -74.0059413

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New York
New York
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Geolocation is 43.16103, -77.6109219

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Rochester
New York
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Geolocation is 35.2270869, -80.8431267

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Charlotte
North Carolina
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Geolocation is 39.6283928, -84.1593818

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Centerville
Ohio
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Geolocation is 35.4675602, -97.5164276

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Oklahoma City
Oklahoma
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Geolocation is 45.5230622, -122.6764816

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Portland
Oregon
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Geolocation is 40.1240795, -75.1195107

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Abington
Pennsylvania
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Geolocation is 41.8137116, -71.3700545

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East Providence
Rhode Island
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Geolocation is 35.9606384, -83.9207392

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Knoxville
Tennessee
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Geolocation is 30.267153, -97.7430608

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Austin
Texas
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Geolocation is 32.7766642, -96.7969879

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Dallas
Texas
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Geolocation is 29.7604267, -95.3698028

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Houston
Texas
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Geolocation is 29.4241219, -98.4936282

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San Antonio
Texas
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Geolocation is 42.8781345, -73.1967741

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Bennington
Vermont
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Geolocation is 37.5407246, -77.4360481

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Richmond
Virginia
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Geolocation is 43.0389025, -87.9064736

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Milwaukee
Wisconsin
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Geolocation is 42.9849233, -81.2452768

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London
Ontario
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Geolocation is 45.4215296, -75.6971931

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Ottawa
Ontario
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Geolocation is 44.309058, -78.319747

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Peterborough
Ontario
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Geolocation is 43.653226, -79.3831843

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Toronto
Ontario
n/a

Geolocation is 45.4853584, -73.4786541

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Greenfield Park
Quebec
n/a

Geolocation is 45.5016889, -73.567256

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Montreal
Quebec
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: 
July 2018
Disease Stage: 
Early
Enrollment: 
800