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221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (EMERGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02484547
Recruitment Status : Active, not recruiting
First Posted : June 29, 2015
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Aducanumab (BIIB037) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 30, 2015
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose
Monthly intravenous (IV) infusions
Drug: Aducanumab (BIIB037)
Low dose

Drug: Placebo
Placebo

Experimental: High Dose
Monthly intravenous (IV) infusions
Drug: Aducanumab (BIIB037)
High dose

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline in CDR-SB score [ Time Frame: Week 78 ]

Secondary Outcome Measures :
  1. Change from baseline in MMSE score [ Time Frame: Week 78 ]
  2. Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 items) (ADAS-Cog 13) [ Time Frame: Week 78 ]
  3. Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL-MCI) score [ Time Frame: Week 78 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
  • A Clinical Dementia Rating (CDR)-Global Score of 0.5.
  • Objective evidence of cognitive impairment at screening
  • An MMSE score between 24 and 30 (inclusive)
  • Must have a positive amyloid Positron Emission Tomography (PET) scan
  • Must consent to apolipoprotein E (ApoE) genotyping
  • If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
  • Must have a reliable informant or caregiver

Key Exclusion Criteria:

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
  • Clinically significant unstable psychiatric illness in 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
  • Have human immunodeficiency virus (HIV) infection
  • Have a significant systematic illness or infection in past 30 days
  • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
  • Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
  • Alcohol or substance abuse in past 1 year
  • Taking blood thinners (except for aspirin at a prophylactic dose or less)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484547


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Xenoscience Inc.
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
Institute for Memory Impairments
Irvine, California, United States, 92607
Renewal Behavioral Health
Long Beach, California, United States, 85013
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Excell Research, Inc.
Oceanside, California, United States, 92056
Pacific Neuroscience Medical Group
Oxnard, California, United States, 93030
Anderson Clinical Research
Redlands, California, United States, 92354
Pacific Research Network
San Diego, California, United States, 92103
University of California San Diego Medical Center
San Diego, California, United States, 92103
California Pacific Medical Center
San Francisco, California, United States, 94114
Syrentis Clinical Research
Santa Ana, California, United States, 92705
St Joseph Heritage Healthcare
Santa Rosa, California, United States, 95403
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University Of Colorado Denver
Aurora, Colorado, United States, 80045
IMMUNOe International Research Centers
Thornton, Colorado, United States, 80233
United States, Connecticut
Associated Neurologists of Southern Connecticut, PC
Fairfield, Connecticut, United States, 06824
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462
Florida Atlantic University
Boca Raton, Florida, United States, 33431
Bradenton Research Center, Inc.
Bradenton, Florida, United States, 34205
Meridien Research
Brooksville, Florida, United States, 34601
Quantum Laboratories Inc.
Deerfield Beach, Florida, United States, 33064
Infinity Clinical Research, LLC
Hollywood, Florida, United States, 33021
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Renstar Medical Research
Ocala, Florida, United States, 34470
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
United States, Georgia
Emory University Cognitive Neurology Clinic & ADRC
Atlanta, Georgia, United States, 30329
Medical Research Health and Education Foundation, Inc
Columbus, Georgia, United States, 31909
NeuroStudies.net, LLC
Decatur, Georgia, United States, 30033
United States, Indiana
Josephson, Wallack, Munshower Neurology, PC
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Boston Center for Memory
Newton, Massachusetts, United States, 05201
United States, Mississippi
Hattiesburg Clinic, PA
Hattiesburg, Mississippi, United States, 39401
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
ActivMed Practices & Research
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
AdvanceMed Research
Lawrenceville, New Jersey, United States, 08648
United States, New York
Empire Neurology, PC
Latham, New York, United States, 12110
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Ohio State University Medical Center
Dublin, Ohio, United States, 43017
United States, Pennsylvania
Lehigh Center for Clinical Research, LLC
Allentown, Pennsylvania, United States, 18104
Penn Memory Center
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Roper St. Francis Healthcare
North Charleston, South Carolina, United States, 29406-6076
United States, Texas
Senior Adult Specialty Research
Austin, Texas, United States, 78757
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Clinical Trial Network
Houston, Texas, United States, 77074
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
United States, Vermont
Clinical Neuroscience Research Association, Inc
Bennington, Vermont, United States, 05201
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Northwest Neurological, PLLC
Spokane, Washington, United States, 99202
Belgium
A.Z. Klina
Brasschaat, Belgium
AZ Sint-Jan Brugge
Brugge, Belgium, 8000
Universitair Ziekenhuis Brussel
Bruxelles, Belgium, 1090
Centre Neurologique & de Réadaptation Fonctionnelle
Fraiture-en-Condroz, Belgium, 4557
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
AZ Groeninge - Campus Kennedylaan
Kortrijk, Belgium, 8500
UZ Leuven
Leuven, Belgium, 3000
AZ Delta
Roeselare, Belgium, 8800
Canada, British Columbia
Health Research.
Kamloops, British Columbia, Canada
Health Research
West Vancouver, British Columbia, Canada
Canada, Nova Scotia
True North Clinical Research - Halifax Inc.
Halifax, Nova Scotia, Canada, B3S 1M7
True North Clinical Research Kentville, Inc
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
JBN Medical Diagnostic Services Inc.
Burlington, Ontario, Canada, L7M 4Y1
St. Joseph's HC- Parkwood Institute
London, Ontario, Canada, N6C 5J1
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada, K9H 2P4
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Recherches Neuro-Hippocampe Inc.
Gatineau, Quebec, Canada, J8T 8J1
Recherche Sepmus, Inc.
Greenfield Park, Quebec, Canada, J4V 2J2
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Douglas Hospital Research Centre
Verdun, Quebec, Canada, H4H 1R3
Finland
Terveystalo Kamppi
Helsinki, Finland, 00100
Itä-Suomen yliopisto, Aivotutkimusyksikkö
Kuopio, Finland, 70210
CRST, Clinical Research Services Turku
Turku, Finland, 20520
France
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France, 13385
CHU de Toulouse - Hôpital Purpan
Toulouse cedex 9, Haute Garonne, France, 31059
Centre de Recherche Clinique du Gérontopôle - Cité de la Santé
Toulouse, Haute Garonne, France, 31052
Hôpital Gui de Chauliac
Montpellier, Herault, France, 34295
CHU Rennes - Hopital Pontchaillou
Rennes cedex 09, Ille Et Vilaine, France, 35033
CHU Nantes - Hopital Nord Laënnec
Nantes cedex 1, Loire Atlantique, France, 44093
Hopital Roger Salengro - CHU Lille
Lille Cedex, Nord, France, 59037
Hôpital des Charpennes
Villeurbanne, Rhone, France, 69100
Hôpital Fernand Widal
Paris, France, 75010
Germany
Bezirkskrankenhaus Guenzburg
Guenzburg, Baden Wuerttemberg, Germany, 89312
ISPG - Institut fuer Studien zur Psychischen Gesundheit
Mannheim, Baden Wuerttemberg, Germany, 68165
Nervenfachaerztlichen Gemeinschaftspraxis Ulm
Ulm, Baden Wuerttemberg, Germany, 89078
Universitaetsklinikum Ulm
Ulm, Baden Wuerttemberg, Germany, 89081
Klinik Hohe Warte Bayreuth
Bayreuth, Bayern, Germany, 95445
Institut fuer Schlaganfall- und Demenzforschung (ISD)
Muenchen, Bayern, Germany, 81377
Klinikum rechts der Isar der TU Muenchen
Muenchen, Bayern, Germany, 81675
Neuropraxis Muenchen Sued
Unterhaching, Bayern, Germany, 82008
Praxis Dr. Kluenemann
Wenzenbach, Bayern, Germany, 93173
Neuro Centrum Odenwald
Erbach, Hessen, Germany, 64711
Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien
Bielefeld, Nordrhein Westfalen, Germany, 33647
Universitaetsklinikum Duesseldorf AoeR
Duesseldorf, Nordrhein Westfalen, Germany, 40629
Universitaetsklinikum Muenster
Muenster, Nordrhein Westfalen, Germany, 48149
Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
Siegen, Nordrhein Westfalen, Germany, 57076
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rheinland Pfalz, Germany, 55131
Klinikum Chemnitz gGmbH
Chemnitz, Sachsen, Germany, 09131
Kopfzentrum Leipzig
Leipzig, Sachsen, Germany, 04275
Klinikum Altenburger Land GmbH
Altenburg, Thueringen, Germany, 04600
emovis GmbH
Berlin, Germany, 10629
Neurologie im Tempelhofer Hafen
Berlin, Germany, 12099
Italy
Ospedale degli Infermi
Ponderano, Biella, Italy, 13875
Azienda Ospedaliera Card. G. Panico
Tricase, Lecce, Italy, 73039
ASST di Monza
Monza, Milano, Italy, 20052
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano, Italy, 20133
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90100
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Italy, 06156
Fondazione Santa Lucia IRCCS
Roma, Italy, 00179
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma, Italy, 00185
Japan
Research Site
Obu-shi, Aichi-Ken, Japan, 474-8511
Research Site
Toon-shi, Ehime-Ken, Japan, 791-0295
Research Site
Fukuoka-shi, Fukuoka-Ken, Japan, 814-0180
Research Site
Kurume-shi, Fukuoka-Ken, Japan, 830-0011
Research Site
Otake-shi, Hiroshima-Ken, Japan, 739-0696
Research Site
Amagasaki-shi, Hyogo-Ken, Japan, 660-8511
Research Site
Himeji-shi, Hyogo-Ken, Japan, 672-8043
Research Site
Kobe-shi, Hyogo-Ken, Japan, 650-0047
Research Site
Kita-gun, Kagawa-Ken, Japan, 761-0793
Research Site
Kyoto-shi, Kyoto-Fu, Japan, 607-8113
Research Site
Kyoto-shi, Kyoto-Fu, Japan, 616-8255
Research Site
Tsu-shi, Mie-Ken, Japan, 514-8507
Research Site
Nishisonogi-gun, Nagasaki-Ken, Japan, 851-2103
Research Site
Yufu-shi, Oita-Ken, Japan, 879-5593
Research Site
Kurashiki-shi, Okayama-Ken, Japan, 710-0813
Research Site
Okayama-shi, Okayama-Ken, Japan, 703-8265
Research Site
Tsukubo-Gun, Okayama-Ken, Japan, 701-0304
Research Site
Kishiwada-shi, Osaka-Fu, Japan, 596-8522
Research Site
Osaka-shi, Osaka-Fu, Japan, 530-0001
Research Site
Osaka-shi, Osaka-Fu, Japan, 530-0005
Research Site
Osaka-shi, Osaka-Fu, Japan, 545-8586
Research Site
Osaka-shi, Osaka-Fu, Japan, 553-0003
Research Site
Sennan-shi, Osaka-Fu, Japan, 590-0503
Research Site
Suita-shi, Osaka-Fu, Japan, 565-0871
Research Site
Toyonaka-Shi, Osaka-Fu, Japan, 560-0004
Research Site
Iwata-shi, Shizuoka-Ken, Japan, 438-0043
Research Site
Shizuoka-shi, Shizuoka-Ken, Japan, 420-8688
Research Site
Shizuoka-shi, Shizuoka-Ken, Japan, 424-8636
Netherlands
Alzheimer Research Center
Amsterdam, Netherlands, 1081 GM
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
Kennemer Gasthuis, Zuid
Haarlem, Netherlands, 2035 RC
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 CE
Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, Poland, 15-732
PALLMED Sp. z o.o.
Bydgoszcz, Poland, 85-796
COPERNICUS Podmiot Leczniczy Sp. z o. o.,
Gdansk, Poland, 80-803
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Novo-Med Zielinski i wspolnicy Sp. j.
Katowice, Poland, 40-650
Neuro-Care Site Management Organization Gabriela Klodowska-Duda
Katowice, Poland, 40-749
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, Poland, 92-216
Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.
Lubin, Poland, 59-300
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-950
Neurologiczny NZOZ Centrum Leczenia SM
Plewiska, Poland, 62-064
NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
Poznan, Poland, 61-853
Centrum Medyczne Medyk
Rzeszow, Poland, 35-055
NZOZ "SENIOR" Poradnia Psychogeriatryczna
Sopot, Poland, 81-855
Osrodek Badan Klinicznych EUROMEDIS
Szczecin, Poland, 70-111
mMED Maciej Czarnecki
Warszawa, Poland, 01-697
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, Poland, 51-124
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 3203
ALTHAIA Hospital Sant Joan de Deu
Manresa, Barcelona, Spain, 08243
Complejo Hospitalario de Caceres
Caceres, Cáceres, Spain, 10003
Hospital Universitario Reina Sofía
Cordoba, Córdoba, Spain, 14011
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Hospital de Basurto
Bilbao, Vizcaya, Spain, 48013
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari Quiron Dexeus
Barcelona, Spain, 08028
Hospital Universitari de Bellvitge
Barcelona, Spain, 8907
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Sweden
Skånes Universitetssjukhus, Malmö
Malmö, Sweden, 20502
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Mölndal, Sweden, 43141
Karolinska Universitetssjukhuset, Huddinge
Stockholm, Sweden, 14186
Akademiska Sjukhuset
Uppsala, Sweden, 75185
Switzerland
Universitären Psychiatrischen Kliniken Basel (UPK)
Basel, Switzerland, 4025
Inselspital - Universitaetsspital Bern
Bern, Switzerland
Medizinisches Zentrum MZB Biel
Biel/Bienne, Switzerland, 2502
Hôpitaux Universitaires de Genève - HUG
Geneve 14, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Ospedale Civico
Lugano, Switzerland, 6903
Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie
Schlieren, Switzerland, 8952
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Additional Information:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02484547     History of Changes
Other Study ID Numbers: 221AD302
2015-000967-15 ( EudraCT Number )
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

Keywords provided by Biogen:
Aducanumab
BIIB037

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders