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BAN2401 for Early Alzheimer's Disease

Start: December 2012
End: February 20, 2025
Enrollment: 800

What Is This Study About?

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.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 90 Years

Must have:

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  

Must NOT have:

  • 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
 

Who Is the General Study Contact?

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

 

Study Contact
Eisai Medical Services

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Alabama
Facility #1
Birmingham, AL 35294
Arizona
Facility #1
Phoenix, AZ 85004
Facility #1
Tucson, AZ 85724
California
Facility #1
Carson, CA 90746
Facility #1
Lomita, CA 90717
Facility #1
Long Beach, CA 90806
Facility #1
Los Alamitos, CA 90720
Facility #1
Los Angeles, CA 90024
Facility #2
Los Angeles, CA 90024
Facility #3
Los Angeles, CA 90024
Facility #1
Orange, CA
Facility #1
Oxnard, CA 93030
Facility #1
San Diego, CA 92123
Colorado
Facility #1
Denver, CO 80239-3133
Connecticut
Facility #1
New Haven, CT 06510
Facility #2
New Haven, CT 06510
Florida
Facility #1
Atlantis, FL 33462
Facility #1
Boca Raton, FL 33431
Facility #2
Boca Raton, FL 33486
Facility #1
Bradenton, FL 34205
Facility #1
Deerfield Beach, FL 33064
Facility #1
Delray Beach, FL 33445
Facility #1
Fort Myers, FL 33912
Facility #1
Hallandale Beach, FL 33009
Facility #1
Hialeah, FL 33016
Facility #1
Lake Worth, FL 33449
Facility #1
Leesburg, FL 34748
Facility #2
Leesburg, FL 34749
Facility #1
Miami, FL 33133
Facility #2
Miami, FL 33137
Facility #3
Miami, FL 33145
Facility #1
Miami Springs, FL 33166
Facility #1
Naples, FL 34102
Facility #1
Ocala, FL 34471
Facility #1
Orlando, FL 32806
Facility #1
Palm Beach Gardens, FL 33410
Facility #1
Saint Petersburg, FL 33713
Facility #1
Sunrise, FL 33351
Facility #3
Tampa, FL 33609
Facility #1
Tampa, FL 33613
Facility #2
Tampa, FL 33613
Facility #1
The Villages, FL
Georgia
Facility #2
Atlanta, GA 30308
Facility #1
Atlanta, GA 30329
Facility #1
Columbus, GA 31909
Facility #1
Decatur, GA 30033
Illinois
Facility #1
Chicago, IL 60640
Facility #1
Elk Grove Village, IL 60007
Indiana
Facility #1
Elkhart, IN 46514
Facility #1
Indianapolis, IN 46202
Kansas
Facility #1
Wichita, KS 67214
Kentucky
Facility #1
Lexington, KY 40504
Massachusetts
Facility #1
Boston, MA 02115
Facility #2
Boston, MA 02118
Facility #1
Burlington, MA 01805
Facility #1
Newton, MA 02459
Michigan
Facility #1
Ann Arbor, MI 48105-2945
Facility #1
East Lansing, MI
Facility #1
Farmington Hills, MI 48334
Facility #1
Lansing, MI 48824
Facility #1
West Bloomfield, MI 48322
Missouri
Facility #1
Saint Louis, MO 63118
New Jersey
Facility #1
Eatontown, NJ 07724
Facility #1
Toms River, NJ 08755
New York
Facility #1
Albany, NY 12206
Facility #1
Amherst, NY 14226
Facility #1
Latham, NY 12110
Facility #1
New York, NY 10016
Facility #2
New York, NY 10021
Facility #1
Rochester, NY 14620
Facility #2
Rochester, NY 14623
North Carolina
Facility #1
Charlotte, NC 28211
Ohio
Facility #1
Centerville, OH 45459
Oklahoma
Facility #1
Oklahoma City, OK 73112
Facility #2
Oklahoma City, OK 73116
Oregon
Facility #2
Portland, OR 97210
Facility #1
Portland, OR 97239
Pennsylvania
Facility #1
Abington, PA 19001
Facility #1
Jenkintown, PA 19046
Rhode Island
Facility #1
East Providence, RI 02914
Tennessee
Facility #1
Knoxville, TN 37920
Texas
Facility #1
Austin, TX 78757
Facility #1
Dallas, TX 75214
Facility #2
Dallas, TX
Facility #1
Houston, TX 77074
Facility #1
San Antonio, TX 78229
Facility #2
San Antonio, TX 78229
Facility #3
San Antonio, TX 78229
Vermont
Facility #1
Bennington, VT 05201
Virginia
Facility #1
Richmond, VA 23294
Wisconsin
Facility #1
Milwaukee, WI 53226

Who Sponsors This Study?

Lead: Eisai Inc.

Source: ClinicalTrials.gov ID: NCT01767311