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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

Facility #1
Phoenix Arizona

Facility #1
Tucson Arizona

Facility #1
Carson California

Facility #1
Lomita California

Facility #1
Long Beach California

Facility #1
Los Alamitos California

Facility #1
Orange California

Facility #1
Oxnard California

Facility #1
San Diego California

Facility #1
Denver Colorado

Facility #1
New Haven Connecticut

Facility #2
New Haven Connecticut

Facility #1
Atlantis Florida

Facility #1
Bradenton Florida

Facility #1
Deerfield Beach Florida

Facility #1
Delray Beach Florida

Facility #1
Fort Myers Florida

Facility #1
Hialeah Florida

Facility #1
Lake Worth Florida

Facility #1
Miami Florida

Facility #2
Miami Florida

Facility #3
Miami Florida

Facility #1
Miami Springs Florida

Facility #1
Ocala Florida

Facility #1
Orlando Florida

Facility #1
Palm Beach Gardens Florida

Facility #1
Sunrise Florida

Facility #2
Tampa Florida

Facility #3
Tampa Florida

Facility #1
The Villages Florida

Facility #1
Atlanta Georgia

Facility #2
Atlanta Georgia

Facility #1
Columbus Georgia

Facility #1
Decatur Georgia

Facility #1
Chicago Illinois

Facility #1
Elk Grove Village Illinois

Facility #1
Elkhart Indiana

Facility #1
Indianapolis Indiana

Facility #1
Wichita Kansas

Facility #1
Lexington Kentucky

Facility #1
Boston Massachusetts

Facility #2
Boston Massachusetts

Facility #1
Burlington Massachusetts

Facility #1
Ann Arbor Michigan

Facility #1
East Lansing Michigan

Facility #1
Farmington Hills Michigan

Facility #1
Eatontown New Jersey

Facility #1
Toms River New Jersey

Facility #1
Albany New York

Facility #1
Amherst New York

Facility #1
Latham New York

Facility #1
New York New York

Facility #1
Rochester New York

Facility #2
Rochester New York

Facility #1
Charlotte North Carolina

Facility #1
Centerville Ohio

Facility #1
Oklahoma City Oklahoma

Facility #2
Oklahoma City Oklahoma

Facility #1
Portland Oregon

Facility #2
Portland Oregon

Facility #1
Abington Pennsylvania

Facility #1
East Providence Rhode Island

Facility #1
Knoxville Tennessee

Facility #1
Austin Texas

Facility #1
Dallas Texas

Facility #2
Dallas Texas

Facility #1
Houston Texas

Facility #1
San Antonio Texas

Facility #3
San Antonio Texas

Facility #1
Bennington Vermont

Facility #1
Richmond Virginia

Facility #1
Milwaukee Wisconsin

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

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