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

Terminated

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.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years All No
September 2015
August 5, 2019
1350

  • 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

  • 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)

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 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
University of Alabama at Birmingham
Birmingham Alabama 35233

Banner Alzheimer's Institute
Phoenix Arizona 85006

Xenoscience Inc.
Phoenix Arizona 85013

Banner Sun Health Research Institute
Sun City Arizona 85351

Institute for Memory Impairments
Irvine California 92607

Renewal Behavioral Health
Long Beach California 85013

USC Keck School of Medicine
Los Angeles California 90033

Hoag Memorial Hospital Presbyterian
Newport Beach California 92663

Excell Research, Inc.
Oceanside California 92056

Pacific Neuroscience Medical Group
Oxnard California 93030

Anderson Clinical Research
Redlands California 92354

Pacific Research Network
San Diego California 92103

University of California San Diego Medical Center
San Diego California 92103

California Pacific Medical Center
San Francisco California 94114

Syrentis Clinical Research
Santa Ana California 92705

St Joseph Heritage Healthcare
Santa Rosa California 95403

Stanford University Medical Center
Stanford California 94305

University Of Colorado Denver
Aurora Colorado 80045

IMMUNOe International Research Centers
Thornton Colorado 80233

Associated Neurologists of Southern Connecticut, PC
Fairfield Connecticut 06824

Yale University School Of Medicine
New Haven Connecticut 06520

Research Center for Clinical Studies, Inc.
Norwalk Connecticut 06851

JEM Research Institute
Atlantis Florida 33462

Florida Atlantic University
Boca Raton Florida 33431

Bradenton Research Center, Inc.
Bradenton Florida 34205

Meridien Research
Brooksville Florida 34601

Quantum Laboratories Inc.
Deerfield Beach Florida 33064

Infinity Clinical Research, LLC
Hollywood Florida 33021

Mayo Clinic in Florida
Jacksonville Florida 32224

Renstar Medical Research
Ocala Florida 34470

Clinical Neuroscience Solutions, Inc.
Orlando Florida 32801

Axiom Clinical Research of Florida
Tampa Florida 33609

Emory University Cognitive Neurology Clinic & ADRC
Atlanta Georgia 30329

Medical Research Health and Education Foundation, Inc
Columbus Georgia 31909

NeuroStudies.net, LLC
Decatur Georgia 30033

Josephson, Wallack, Munshower Neurology, PC
Indianapolis Indiana 46256

McLean Hospital
Belmont Massachusetts 02478

Boston Center for Memory
Newton Massachusetts 05201

Hattiesburg Clinic, PA
Hattiesburg Mississippi 39401

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada 89106

ActivMed Practices & Research
Portsmouth New Hampshire 03801

AdvanceMed Research
Lawrenceville New Jersey 08648

Empire Neurology, PC
Latham New York 12110

Weill Cornell Medical College-New York Presbyterian Hospital
New York New York 10021

Mount Sinai School of Medicine
New York New York 10029

PMG Research of Winston-Salem, LLC
Winston-Salem North Carolina 27103

Wake Forest Baptist Health
Winston-Salem North Carolina 27103

Ohio State University Medical Center
Dublin Ohio 43017

Lehigh Center for Clinical Research, LLC
Allentown Pennsylvania 18104

Penn Memory Center
Philadelphia Pennsylvania 19104

Rhode Island Hospital
Providence Rhode Island 02903

Roper St. Francis Healthcare
North Charleston South Carolina 29406-6076

Senior Adult Specialty Research
Austin Texas 78757

The Methodist Hospital Research Institute
Houston Texas 77030

Clinical Trial Network
Houston Texas 77074

University of Utah Health Sciences Center
Salt Lake City Utah 84132

Clinical Neuroscience Research Association, Inc
Bennington Vermont 05201

University of Washington Medical Center
Seattle Washington 98195

Northwest Neurological, PLLC
Spokane Washington 99202

Health Research.
Kamloops British Columbia

Health Research
West Vancouver British Columbia

True North Clinical Research - Halifax Inc.
Halifax Nova Scotia B3S 1M7

True North Clinical Research Kentville, Inc
Kentville Nova Scotia B4N 4K9

JBN Medical Diagnostic Services Inc.
Burlington Ontario L7M 4Y1

St. Joseph's HC- Parkwood Institute
London Ontario N6C 5J1

Bruyere Continuing Care
Ottawa Ontario K1N 5C8

Kawartha Regional Memory Clinic
Peterborough Ontario K9H 2P4

Toronto Western Hospital
Toronto Ontario M5T 2S8

Recherches Neuro-Hippocampe Inc.
Gatineau Quebec J8T 8J1

Recherche Sepmus, Inc.
Greenfield Park Quebec J4V 2J2

DIEX Recherche Sherbrooke Inc.
Sherbrooke Quebec J1H 1Z1

Douglas Hospital Research Centre
Verdun Quebec H4H 1R3

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

NCT02484547

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