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

Terminated

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.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years All No
June 2015
August 8, 2019
1350

  • 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

  • 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)

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. Two doses of aducanumab drug will be tested. Participants' cognition and functioning will be assessed with the Clinical Dementia Rating-Sum of Boxes, Mini-Mental State Examination, Alzheimer's Disease Assessment Scale-Cognitive Subscale, and Alzheimer's Cooperative Study-Activities of Daily Living Inventory.

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

Name City State Zip Status Primary Contact
St. Joseph's Hospital and Medical Center
Phoenix Arizona 85013

Center for Neurosciences
Tucson Arizona 85718

Neurology Center of North Orange County
Fullerton California 92835

Senior Clinical Trials, Inc.
Laguna Hills California 92653

Torrance Clinical Research Institute, Inc.
Lomita California 90717

University of California - Los Angeles
Los Angeles California 90095

UCSF - Memory and Aging Center
San Francisco California 94158

California Neuroscience Research Medical Group Inc.
Sherman Oaks California 91403

Southern California Research LLC
Simi Valley California 93065

Institute for Neurodegenerative Disorders
New Haven Connecticut 06510

Georgetown University Hospital
Washington District of Columbia 20057

Brain Matters Research, Inc.
Delray Beach Florida 33445

Neuropsychiatric Research Center of Southwest Florida
Fort Myers Florida 33912

Jacksonville Center for Clinical Research
Jacksonville Florida 32216

University of Miami
Miami Florida 33136

Miami Jewish Health Systems
Miami Florida 33137

Compass Research Main
Orlando Florida 32806

Palm Beach Neurological Center
Palm Beach Gardens Florida 33410

Stedman Clinical Trials, LLC
Tampa Florida 33613

USF Health Byrd Institute
Tampa Florida 33616

Meridien Research
Tampa Florida 33634

Compass Research Main
The Villages Florida 32162

Premiere Research Institute
West Palm Beach Florida 33407

Cleveland Clinic Florida - Weston
Weston Florida 33331

Alexian Brothers Neurosciences Institute
Elk Grove Village Illinois 60007

Advocate Lutheran General Hospital
Park Ridge Illinois 60068

Fort Wayne Neurological Center
Fort Wayne Indiana 46804

Indiana University School of Medicine
Indianapolis Indiana 46202

University of Kansas Medical Center Research Institute, Inc.
Kansas City Kansas 66160

Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita Kansas 67214

Baptist Health Lexington
Lexington Kentucky 40503

Brigham & Women's Hosp End/Dbt
Boston Massachusetts 02115

Beth Israel Deaconess Medical Center
Boston Massachusetts 02215

ActivMed Practices & Research
Methuen Massachusetts 01844

Donald S. Marks, M.D., P.C.
Plymouth Massachusetts 02360

Mayo Clinic
Rochester Minnesota 55905

Washington University
Saint Louis Missouri 63131

Las Vegas Medical research
Las Vegas Nevada 89113

Advanced Memory Research Institute of NJ, PC
Toms River New Jersey 08755

Albany Medical College
Albany New York 12208

New York University Medical Center PRIME
New York New York 10016

University of Rochester
Rochester New York 14620

ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
Charlotte North Carolina 28270

Raleigh Neurology Associates, P.A.
Raleigh North Carolina 27607-6010

Cleveland Clinic
Cleveland Ohio 44195

Lynn Health Science Institute
Oklahoma City Oklahoma 73112

The Clinical Trial Center, LLC
Jenkintown Pennsylvania 19046

University of Pittsburgh
Pittsburgh Pennsylvania 15213

Northeastern Pennsylvania Memory and Alzheimer's Center
Plains Pennsylvania 18705

Rhode Island Mood & Memory Research Institute
East Providence Rhode Island 02915

Butler Hospital
Providence Rhode Island 02906

Medical University of South Carolina (MUSC)
Charleston South Carolina 29425

Neurology Clinic, PC
Cordova Tennessee 38108

University of Tennessee Medical Center. Knoxville
Knoxville Tennessee 37920

Clinical Neuroscience Solutions, Inc.
Memphis Tennessee 38119

UT Southwestern Medical Center at Dallas
Dallas Texas 75390

Baylor College of Medicine
Houston Texas 77030

National Clinical Research Inc.-Richmond
Richmond Virginia 23294

Medical College of Wisconsin, Inc.
Milwaukee Wisconsin 53266

CHU de Quebec - Hôpital de l' Enfant Jésus
Quebec G1J 1Z4

Heritage Medical Research Clinic
Calgary Alberta T2N 1N4

The Medical Arts Health Research Group
Penticton British Columbia V2A 5C8

UBC Hospital
Vancouver British Columbia V6T 2B5

Toronto Memory Program (Neurology Research Inc.)
Toronto Ontario M3B 2S7

Toronto Sunnybrook Hospital
Toronto Ontario M4N 3M5

The Montreal Neurological Institute
Montreal Quebec H3A 2B4

McGill Centre for Studies in Aging
Verdun Quebec H4H 1R3

Name Phone Email
Aducanumab US Call Center 877-231-7271 clinicaltrials@biogen.com

NCT02477800

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease