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 | |
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St. Joseph's Hospital and Medical Center
Phoenix, AZ 85013
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Center for Neurosciences
Tucson, AZ 85718
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| California | |
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Neurology Center of North Orange County
Fullerton, CA 92835
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Senior Clinical Trials, Inc.
Laguna Hills, CA 92653
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Torrance Clinical Research Institute, Inc.
Lomita, CA 90717
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University of California - Los Angeles
Los Angeles, CA 90095
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UCSF - Memory and Aging Center
San Francisco, CA 94158
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California Neuroscience Research Medical Group Inc.
Sherman Oaks, CA 91403
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Southern California Research LLC
Simi Valley, CA 93065
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| Connecticut | |
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Institute for Neurodegenerative Disorders
New Haven, CT 06510
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| District of Columbia | |
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Georgetown University Hospital
Washington, DC 20057
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| Florida | |
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Brain Matters Research, Inc.
Delray Beach, FL 33445
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Neuropsychiatric Research Center of Southwest Florida
Fort Myers, FL 33912
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Jacksonville Center for Clinical Research
Jacksonville, FL 32216
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University of Miami
Miami, FL 33136
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Miami Jewish Health Systems
Miami, FL 33137
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Compass Research Main
Orlando, FL 32806
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Palm Beach Neurological Center
Palm Beach Gardens, FL 33410
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Stedman Clinical Trials, LLC
Tampa, FL 33613
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USF Health Byrd Institute
Tampa, FL 33616
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Meridien Research
Tampa, FL 33634
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Compass Research Main
The Villages, FL 32162
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Premiere Research Institute
West Palm Beach, FL 33407
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Cleveland Clinic Florida - Weston
Weston, FL 33331
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| Illinois | |
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Alexian Brothers Neurosciences Institute
Elk Grove Village, IL 60007
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Advocate Lutheran General Hospital
Park Ridge, IL 60068
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| Indiana | |
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Fort Wayne Neurological Center
Fort Wayne, IN 46804
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Indiana University School of Medicine
Indianapolis, IN 46202
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| Kansas | |
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University of Kansas Medical Center Research Institute, Inc.
Kansas City, KS 66160
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Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita, KS 67214
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| Kentucky | |
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Baptist Health Lexington
Lexington, KY 40503
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| Massachusetts | |
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Brigham & Women's Hosp End/Dbt
Boston, MA 02115
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Beth Israel Deaconess Medical Center
Boston, MA 02215
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ActivMed Practices & Research
Methuen, MA 01844
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Donald S. Marks, M.D., P.C.
Plymouth, MA 02360
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| Minnesota | |
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Mayo Clinic
Rochester, MN 55905
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| Missouri | |
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Washington University
Saint Louis, MO 63131
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| Nevada | |
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Las Vegas Medical research
Las Vegas, NV 89113
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| New Jersey | |
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Advanced Memory Research Institute of NJ, PC
Toms River, NJ 08755
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| New York | |
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Albany Medical College
Albany, NY 12208
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New York University Medical Center PRIME
New York, NY 10016
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University of Rochester
Rochester, NY 14620
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| North Carolina | |
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ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
Charlotte, NC 28270
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Raleigh Neurology Associates, P.A.
Raleigh, NC 27607-6010
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| Ohio | |
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Cleveland Clinic
Cleveland, OH 44195
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| Oklahoma | |
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Lynn Health Science Institute
Oklahoma City, OK 73112
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| Pennsylvania | |
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The Clinical Trial Center, LLC
Jenkintown, PA 19046
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University of Pittsburgh
Pittsburgh, PA 15213
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Northeastern Pennsylvania Memory and Alzheimer's Center
Plains, PA 18705
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| Rhode Island | |
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Rhode Island Mood & Memory Research Institute
East Providence, RI 02915
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Butler Hospital
Providence, RI 02906
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| South Carolina | |
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Medical University of South Carolina (MUSC)
Charleston, SC 29425
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| Tennessee | |
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Neurology Clinic, PC
Cordova, TN 38108
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University of Tennessee Medical Center. Knoxville
Knoxville, TN 37920
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Clinical Neuroscience Solutions, Inc.
Memphis, TN 38119
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| Texas | |
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UT Southwestern Medical Center at Dallas
Dallas, TX 75390
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Baylor College of Medicine
Houston, TX 77030
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| Virginia | |
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National Clinical Research Inc.-Richmond
Richmond, VA 23294
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| Wisconsin | |
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Medical College of Wisconsin, Inc.
Milwaukee, WI 53266
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CHU de Quebec - Hôpital de l' Enfant Jésus
Quebec, G1J 1Z4
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| Alberta | |
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Heritage Medical Research Clinic
Calgary, AB T2N 1N4
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| British Columbia | |
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The Medical Arts Health Research Group
Penticton, BC V2A 5C8
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UBC Hospital
Vancouver, BC V6T 2B5
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| Ontario | |
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Toronto Memory Program (Neurology Research Inc.)
Toronto, ON M3B 2S7
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Toronto Sunnybrook Hospital
Toronto, ON M4N 3M5
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| Quebec | |
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The Montreal Neurological Institute
Montreal, QC H3A 2B4
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McGill Centre for Studies in Aging
Verdun, QC H4H 1R3
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Who Sponsors This Study?
Lead:
Source: ClinicalTrials.gov ID: NCT02477800