Skip to main content
Find more clinical trials

ENGAGE: Aducanumab (BIIB037) for Early Alzheimer's Disease

Start: June 2015
End: August 8, 2019
Enrollment: 1350

What Is This Study About?

The primary objective of this Phase III study is to evaluate the efficacy of the experimental drug aducanumab (BIIB037), compared with a placebo, in slowing cognitive and functional impairment in people with early-stage Alzheimer's disease. Participants will receive monthly infusions.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 85 Years

Must have:

  • Must meet clinical criteria for mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's
  • Clinical Dementia Rating-Global Score of 0.5
  • Objective evidence of cognitive impairment at screening
  • Mini-Mental State Examination score of 24-30 (inclusive)
  • Positive amyloid positron emission tomography (PET) scan
  • Consent to apolipoprotein E genotyping
  • If taking Alzheimer's medications, dose must be stable for at least 8 weeks prior to first screening visit
  • Reliable informant or caregiver

Must NOT have:

  • Any medical or neurological condition (other than Alzheimer's disease) that might contribute to cognitive impairment
  • Stroke, transient ischemic attack (TIA), or unexplained loss of consciousness in the past year
  • Clinically significant psychiatric illness in the past 6 months
  • History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to screening
  • Impaired renal or liver function
  • Human immunodeficiency virus (HIV) infection
  • Significant systematic illness or infection in the past 30 days
  • Relevant brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities
  • Any contraindication to brain scans
  • Alcohol or substance abuse in the past year
  • Taking blood thinner medication (except for aspirin at a prophylactic dose or less)

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Study Contact
Aducanumab US Call Center
877-231-7271
clinicaltrials@biogen.com

Need Help?

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

Who Is the General Study Contact?

For more information about this study or study sites, contact the Aducanumab US Call Center at 877-231-7271 or clinicaltrials@biogen.com.

Where Is This Study Located?

Arizona
St. Joseph's Hospital and Medical Center
Phoenix, AZ 85013
Center for Neurosciences
Tucson, AZ 85718
California
Neurology Center of North Orange County
Fullerton, CA 92835
Senior Clinical Trials, Inc.
Laguna Hills, CA 92653
Torrance Clinical Research Institute, Inc.
Lomita, CA 90717
University of California - Los Angeles
Los Angeles, CA 90095
UCSF - Memory and Aging Center
San Francisco, CA 94158
California Neuroscience Research Medical Group Inc.
Sherman Oaks, CA 91403
Southern California Research LLC
Simi Valley, CA 93065
Connecticut
Institute for Neurodegenerative Disorders
New Haven, CT 06510
District of Columbia
Georgetown University Hospital
Washington, DC 20057
Florida
Brain Matters Research, Inc.
Delray Beach, FL 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, FL 33912
Jacksonville Center for Clinical Research
Jacksonville, FL 32216
University of Miami
Miami, FL 33136
Miami Jewish Health Systems
Miami, FL 33137
Compass Research Main
Orlando, FL 32806
Palm Beach Neurological Center
Palm Beach Gardens, FL 33410
Stedman Clinical Trials, LLC
Tampa, FL 33613
USF Health Byrd Institute
Tampa, FL 33616
Meridien Research
Tampa, FL 33634
Compass Research Main
The Villages, FL 32162
Premiere Research Institute
West Palm Beach, FL 33407
Cleveland Clinic Florida - Weston
Weston, FL 33331
Illinois
Alexian Brothers Neurosciences Institute
Elk Grove Village, IL 60007
Advocate Lutheran General Hospital
Park Ridge, IL 60068
Indiana
Fort Wayne Neurological Center
Fort Wayne, IN 46804
Indiana University School of Medicine
Indianapolis, IN 46202
Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City, KS 66160
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita, KS 67214
Kentucky
Baptist Health Lexington
Lexington, KY 40503
Massachusetts
Brigham & Women's Hosp End/Dbt
Boston, MA 02115
Beth Israel Deaconess Medical Center
Boston, MA 02215
ActivMed Practices & Research
Methuen, MA 01844
Donald S. Marks, M.D., P.C.
Plymouth, MA 02360
Minnesota
Mayo Clinic
Rochester, MN 55905
Missouri
Washington University
Saint Louis, MO 63131
Nevada
Las Vegas Medical research
Las Vegas, NV 89113
New Jersey
Advanced Memory Research Institute of NJ, PC
Toms River, NJ 08755
New York
Albany Medical College
Albany, NY 12208
New York University Medical Center PRIME
New York, NY 10016
University of Rochester
Rochester, NY 14620
North Carolina
ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
Charlotte, NC 28270
Raleigh Neurology Associates, P.A.
Raleigh, NC 27607-6010
Ohio
Cleveland Clinic
Cleveland, OH 44195
Oklahoma
Lynn Health Science Institute
Oklahoma City, OK 73112
Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, PA 19046
University of Pittsburgh
Pittsburgh, PA 15213
Northeastern Pennsylvania Memory and Alzheimer's Center
Plains, PA 18705
Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, RI 02915
Butler Hospital
Providence, RI 02906
South Carolina
Medical University of South Carolina (MUSC)
Charleston, SC 29425
Tennessee
Neurology Clinic, PC
Cordova, TN 38108
University of Tennessee Medical Center. Knoxville
Knoxville, TN 37920
Clinical Neuroscience Solutions, Inc.
Memphis, TN 38119
Texas
UT Southwestern Medical Center at Dallas
Dallas, TX 75390
Baylor College of Medicine
Houston, TX 77030
Virginia
National Clinical Research Inc.-Richmond
Richmond, VA 23294
Wisconsin
Medical College of Wisconsin, Inc.
Milwaukee, WI 53266
CHU de Quebec - Hôpital de l' Enfant Jésus
Quebec, G1J 1Z4
Alberta
Heritage Medical Research Clinic
Calgary, AB T2N 1N4
British Columbia
The Medical Arts Health Research Group
Penticton, BC V2A 5C8
UBC Hospital
Vancouver, BC V6T 2B5
Ontario
Toronto Memory Program (Neurology Research Inc.)
Toronto, ON M3B 2S7
Toronto Sunnybrook Hospital
Toronto, ON M4N 3M5
Quebec
The Montreal Neurological Institute
Montreal, QC H3A 2B4
McGill Centre for Studies in Aging
Verdun, QC H4H 1R3

Who Sponsors This Study?

Lead:

Source: ClinicalTrials.gov ID: NCT02477800