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BAN2401 for Early Alzheimer's Disease

Active, not recruiting

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.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years Both No
December 2012
July 2018
800

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  

  • 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

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.

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

 

Name City State Zip Status Primary Contact
Facility #1
Birmingham Alabama 35294

Facility #1
Phoenix Arizona 85004

Facility #1
Tucson Arizona 85724

Facility #1
Carson California 90746

Facility #1
Lomita California 90717

Facility #1
Long Beach California 90806

Facility #1
Los Alamitos California 90720

Facility #1
Los Angeles California 90024

Facility #2
Los Angeles California 90024

Facility #3
Los Angeles California 90024

Facility #1
Orange California

Facility #1
Oxnard California 93030

Facility #1
San Diego California 92123

Facility #1
Denver Colorado 80239-3133

Facility #1
New Haven Connecticut 06510

Facility #2
New Haven Connecticut 06510

Facility #1
Atlantis Florida 33462

Facility #1
Boca Raton Florida 33431

Facility #2
Boca Raton Florida 33486

Facility #1
Bradenton Florida 34205

Facility #1
Deerfield Beach Florida 33064

Facility #1
Delray Beach Florida 33445

Facility #1
Fort Myers Florida 33912

Facility #1
Hallandale Beach Florida 33009

Facility #1
Hialeah Florida 33016

Facility #1
Lake Worth Florida 33449

Facility #1
Leesburg Florida 34748

Facility #2
Leesburg Florida 34749

Facility #1
Miami Florida 33133

Facility #2
Miami Florida 33137

Facility #3
Miami Florida 33145

Facility #1
Miami Springs Florida 33166

Facility #1
Naples Florida 34102

Facility #1
Ocala Florida 34471

Facility #1
Orlando Florida 32806

Facility #1
Palm Beach Gardens Florida 33410

Facility #1
Saint Petersburg Florida 33713

Facility #1
Sunrise Florida 33351

Facility #3
Tampa Florida 33609

Facility #1
Tampa Florida 33613

Facility #2
Tampa Florida 33613

Facility #1
The Villages Florida

Facility #2
Atlanta Georgia 30308

Facility #1
Atlanta Georgia 30329

Facility #1
Columbus Georgia 31909

Facility #1
Decatur Georgia 30033

Facility #1
Chicago Illinois 60640

Facility #1
Elk Grove Village Illinois 60007

Facility #1
Elkhart Indiana 46514

Facility #1
Indianapolis Indiana 46202

Facility #1
Wichita Kansas 67214

Facility #1
Lexington Kentucky 40504

Facility #1
Boston Massachusetts 02115

Facility #2
Boston Massachusetts 02118

Facility #1
Burlington Massachusetts 01805

Facility #1
Newton Massachusetts 02459

Facility #1
Ann Arbor Michigan 48105-2945

Facility #1
East Lansing Michigan

Facility #1
Farmington Hills Michigan 48334

Facility #1
Lansing Michigan 48824

Facility #1
West Bloomfield Michigan 48322

Facility #1
Saint Louis Missouri 63118

Facility #1
Eatontown New Jersey 07724

Facility #1
Toms River New Jersey 08755

Facility #1
Albany New York 12206

Facility #1
Amherst New York 14226

Facility #1
Latham New York 12110

Facility #1
New York New York 10016

Facility #2
New York New York 10021

Facility #1
Rochester New York 14620

Facility #2
Rochester New York 14623

Facility #1
Charlotte North Carolina 28211

Facility #1
Centerville Ohio 45459

Facility #1
Oklahoma City Oklahoma 73112

Facility #2
Oklahoma City Oklahoma 73116

Facility #2
Portland Oregon 97210

Facility #1
Portland Oregon 97239

Facility #1
Abington Pennsylvania 19001

Facility #1
Jenkintown Pennsylvania 19046

Facility #1
East Providence Rhode Island 02914

Facility #1
Knoxville Tennessee 37920

Facility #1
Austin Texas 78757

Facility #1
Dallas Texas 75214

Facility #2
Dallas Texas

Facility #1
Houston Texas 77074

Facility #1
San Antonio Texas 78229

Facility #2
San Antonio Texas 78229

Facility #3
San Antonio Texas 78229

Facility #1
Bennington Vermont 05201

Facility #1
Richmond Virginia 23294

Facility #1
Milwaukee Wisconsin 53226

Facility #1
Québec city

Facility #1
Kentville Nova Scotia

Facility #1
Kingston Ontario

Facility #2
London Ontario

Facility #1
Ottawa Ontario

Facility #1
Peterborough Ontario

Facility #1
Toronto Ontario

Facility #1
Greenfield Park Quebec

Facility #1
Montreal Quebec

Facility #1
Verdun Quebec

Eisai Inc.

Name Role Affiliation
Chad Swanson Study Director Eisai Inc.

Name Phone Email
Eisai Medical Services 888-422-4743

NCT01767311

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