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

Start: September 2015
End: August 5, 2019
Enrollment: 1350

What Is This Study About?

This study will 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: 50 Years

Maximum Age: 85 Years

Must have:

  • Mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's disease
  • 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 medication, must be on stable dose for at least 8 weeks prior to screening
  • Reliable informant or caregiver

Must NOT have:

  • Any medical or neurological condition other than Alzheimer's that might be a contributing cause of cognitive impairment
  • Stroke, transient ischemic attack, 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
  • Indication of 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, cerebrovascular abnormalities
  • Any contraindications to brain magnetic resonance imaging or PET scans
  • Alcohol or substance abuse in the past year
  • Taking blood thinners (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?

Alabama
University of Alabama at Birmingham
Birmingham, AL 35233
Arizona
Banner Alzheimer's Institute
Phoenix, AZ 85006
Xenoscience Inc.
Phoenix, AZ 85013
Banner Sun Health Research Institute
Sun City, AZ 85351
California
Institute for Memory Impairments
Irvine, CA 92607
Renewal Behavioral Health
Long Beach, CA 85013
USC Keck School of Medicine
Los Angeles, CA 90033
Hoag Memorial Hospital Presbyterian
Newport Beach, CA 92663
Excell Research, Inc.
Oceanside, CA 92056
Pacific Neuroscience Medical Group
Oxnard, CA 93030
Anderson Clinical Research
Redlands, CA 92354
Pacific Research Network
San Diego, CA 92103
University of California San Diego Medical Center
San Diego, CA 92103
California Pacific Medical Center
San Francisco, CA 94114
Syrentis Clinical Research
Santa Ana, CA 92705
St Joseph Heritage Healthcare
Santa Rosa, CA 95403
Stanford University Medical Center
Stanford, CA 94305
Colorado
University Of Colorado Denver
Aurora, CO 80045
IMMUNOe International Research Centers
Thornton, CO 80233
Connecticut
Associated Neurologists of Southern Connecticut, PC
Fairfield, CT 06824
Yale University School Of Medicine
New Haven, CT 06520
Research Center for Clinical Studies, Inc.
Norwalk, CT 06851
Florida
JEM Research Institute
Atlantis, FL 33462
Florida Atlantic University
Boca Raton, FL 33431
Bradenton Research Center, Inc.
Bradenton, FL 34205
Meridien Research
Brooksville, FL 34601
Quantum Laboratories Inc.
Deerfield Beach, FL 33064
Infinity Clinical Research, LLC
Hollywood, FL 33021
Mayo Clinic in Florida
Jacksonville, FL 32224
Renstar Medical Research
Ocala, FL 34470
Clinical Neuroscience Solutions, Inc.
Orlando, FL 32801
Axiom Clinical Research of Florida
Tampa, FL 33609
Georgia
Emory University Cognitive Neurology Clinic & ADRC
Atlanta, GA 30329
Medical Research Health and Education Foundation, Inc
Columbus, GA 31909
NeuroStudies.net, LLC
Decatur, GA 30033
Indiana
Josephson, Wallack, Munshower Neurology, PC
Indianapolis, IN 46256
Massachusetts
McLean Hospital
Belmont, MA 02478
Boston Center for Memory
Newton, MA 05201
Mississippi
Hattiesburg Clinic, PA
Hattiesburg, MS 39401
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, NV 89106
New Hampshire
ActivMed Practices & Research
Portsmouth, NH 03801
New Jersey
AdvanceMed Research
Lawrenceville, NJ 08648
New York
Empire Neurology, PC
Latham, NY 12110
Weill Cornell Medical College-New York Presbyterian Hospital
New York, NY 10021
Mount Sinai School of Medicine
New York, NY 10029
North Carolina
PMG Research of Winston-Salem, LLC
Winston-Salem, NC 27103
Wake Forest Baptist Health
Winston-Salem, NC 27103
Ohio
Ohio State University Medical Center
Dublin, OH 43017
Pennsylvania
Lehigh Center for Clinical Research, LLC
Allentown, PA 18104
Penn Memory Center
Philadelphia, PA 19104
Rhode Island
Rhode Island Hospital
Providence, RI 02903
South Carolina
Roper St. Francis Healthcare
North Charleston, SC 29406-6076
Texas
Senior Adult Specialty Research
Austin, TX 78757
The Methodist Hospital Research Institute
Houston, TX 77030
Clinical Trial Network
Houston, TX 77074
Utah
University of Utah Health Sciences Center
Salt Lake City, UT 84132
Vermont
Clinical Neuroscience Research Association, Inc
Bennington, VT 05201
Washington
University of Washington Medical Center
Seattle, WA 98195
Northwest Neurological, PLLC
Spokane, WA 99202
British Columbia
Health Research.
Kamloops, BC
Health Research
West Vancouver, BC
Nova Scotia
True North Clinical Research - Halifax Inc.
Halifax, NS B3S 1M7
True North Clinical Research Kentville, Inc
Kentville, NS B4N 4K9
Ontario
JBN Medical Diagnostic Services Inc.
Burlington, ON L7M 4Y1
St. Joseph's HC- Parkwood Institute
London, ON N6C 5J1
Bruyere Continuing Care
Ottawa, ON K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, ON K9H 2P4
Toronto Western Hospital
Toronto, ON M5T 2S8
Quebec
Recherches Neuro-Hippocampe Inc.
Gatineau, QC J8T 8J1
Recherche Sepmus, Inc.
Greenfield Park, QC J4V 2J2
DIEX Recherche Sherbrooke Inc.
Sherbrooke, QC J1H 1Z1
Douglas Hospital Research Centre
Verdun, QC H4H 1R3

Who Sponsors This Study?

Lead:

Source: ClinicalTrials.gov ID: NCT02484547