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

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

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].

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Aducanumab (BIIB037); Drug: Aducanumab (BIIB037)

• Study Type: Interventional
• Enrollment (Actual): 1643
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brasschaat, Belgium
    • A.Z. Klina
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge
  • Bruxelles, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Fraiture, Belgium, 4557
    • Centre Neurologique & de Réadaptation Fonctionnelle
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - Campus Kennedylaan
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Roeselare, Belgium, 8800
    • AZ DELTA
• Canada
  • British Columbia
    • Kamloops, British Columbia, Canada
      • Health Research.
    • West Vancouver, British Columbia, Canada
      • Health Research
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3S 1M7
      • True North Clinical Research - Halifax Inc.
    • Kentville, Nova Scotia, Canada, B4N 4K9
      • True North Clinical Research Kentville, Inc
  • Ontario
    • Burlington, Ontario, Canada, L7M 4Y1
      • JBN Medical Diagnostic Services Inc.
    • London, Ontario, Canada, N6C 5J1
      • St. Joseph's HC- Parkwood Institute
    • Ottawa, Ontario, Canada, K1N 5C8
      • Bruyere Continuing Care
    • Peterborough, Ontario, Canada, K9H 2P4
      • Kawartha Regional Memory Clinic
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
  • Quebec
    • Gatineau, Quebec, Canada, J8T 8J1
      • Recherches Neuro-Hippocampe Inc.
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Recherche Sepmus, Inc.
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • DIEX Recherche Sherbrooke Inc.
    • Verdun, Quebec, Canada, H4H 1R3
      • Douglas Hospital Research Centre
• Finland
  • Helsinki, Finland, 00100
    • Terveystalo Kamppi
  • Kuopio, Finland, 70210
    • Itä-Suomen yliopisto, Aivotutkimusyksikkö
  • Turku, Finland, 20520
    • CRST, Clinical Research Services Turku
• France
  • Paris, France, 75010
    • Hopital Fernand Widal
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13385
      • Hopital de la Timone
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31052
      • Centre de Recherche Clinique du Gérontopôle - Cité de la Santé
    • Toulouse cedex 9, Haute Garonne, France, 31059
      • CHU de Toulouse - Hôpital Purpan
  • Herault
    • Montpellier, Herault, France, 34295
      • Hopital Gui de Chauliac
  • Ille Et Vilaine
    • Rennes cedex 09, Ille Et Vilaine, France, 35033
      • CHU Rennes - Hôpital Pontchaillou
  • Loire Atlantique
    • Nantes cedex 1, Loire Atlantique, France, 44093
      • CHU Nantes - Hopital Nord Laënnec
  • Nord
    • Lille Cedex, Nord, France, 59037
      • Hopital Roger Salengro - CHU Lille
  • Rhone
    • Villeurbanne, Rhone, France, 69100
      • Hôpital des charpennes
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 12099
    • Neurologie im Tempelhofer Hafen
  • Baden Wuerttemberg
    • Gunzburg, Baden Wuerttemberg, Germany, 89312
      • Bezirkskrankenhaus Guenzburg
    • Mannheim, Baden Wuerttemberg, Germany, 68165
      • ISPG - Institut fuer Studien zur Psychischen Gesundheit
    • Ulm, Baden Wuerttemberg, Germany, 89081
      • Universitaetsklinikum Ulm
    • Ulm, Baden Wuerttemberg, Germany, 89078
      • Nervenfachaerztlichen Gemeinschaftspraxis Ulm
  • Bayern
    • Bayreuth, Bayern, Germany, 95445
      • Klinik Hohe Warte Bayreuth
    • Muenchen, Bayern, Germany, 81675
      • Klinikum rechts der Isar der TU Muenchen
    • Muenchen, Bayern, Germany, 81377
      • Institut fuer Schlaganfall- und Demenzforschung (ISD)
    • Unterhaching, Bayern, Germany, 82008
      • Neuropraxis Muenchen Sued
  • Hessen
    • Erbach, Hessen, Germany, 64711
      • Neuro Centrum Odenwald
  • Nordrhein Westfalen
    • Duesseldorf, Nordrhein Westfalen, Germany, 40629
      • Universitaetsklinikum Duesseldorf AoeR
    • Muenster, Nordrhein Westfalen, Germany, 48149
      • Universitaetsklinikum Muenster
    • Siegen, Nordrhein Westfalen, Germany, 57076
      • Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
  • North Rhine-Westphalia
    • Bielefeld, North Rhine-Westphalia, Germany, 33647
      • Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien
  • Rheinland Pfalz
    • Mainz, Rheinland Pfalz, Germany, 55131
      • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09131
      • Klinikum Chemnitz gGmbH
    • Leipzig, Sachsen, Germany, 04275
      • Kopfzentrum Leipzig
  • Thueringen
    • Altenburg, Thueringen, Germany, 04600
      • Klinikum Altenburger Land GmbH
• Italy
  • Milano, Italy, 20133
    • Fondazione IRCCS Istituto Neurologico Carlo Besta
  • Palermo, Italy, 90100
    • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Perugia, Italy, 06156
    • Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia
  • Roma, Italy, 00179
    • Fondazione Santa Lucia IRCCS
  • Roma, Italy, 00185
    • Umberto I Pol. di Roma-Università di Roma La Sapienza
  • Biella
    • Ponderano, Biella, Italy, 13875
      • Ospedale Degli Infermi
  • Lecce
    • Tricase, Lecce, Italy, 73039
      • Azienda Ospedaliera Card. G. Panico
  • Milano
    • Monza, Milano, Italy, 20052
      • ASST di Monza
• Japan
  • Aichi-Ken
    • Obu-shi, Aichi-Ken, Japan, 474-8511
      • Research Site
  • Ehime-Ken
    • Toon-shi, Ehime-Ken, Japan, 791-0295
      • Research Site
  • Fukuoka-Ken
    • Fukuoka-shi, Fukuoka-Ken, Japan, 814-0180
      • Research Site
    • Kurume-shi, Fukuoka-Ken, Japan, 830-0011
      • Research Site
  • Hiroshima-Ken
    • Otake-shi, Hiroshima-Ken, Japan, 739-0696
      • Research Site
  • Hyogo-Ken
    • Amagasaki-shi, Hyogo-Ken, Japan, 660-8511
      • Research Site
    • Himeji-shi, Hyogo-Ken, Japan, 670-0981
      • Research Site
    • Himeji-shi, Hyogo-Ken, Japan, 672-8043
      • Research Site
    • Kobe-shi, Hyogo-Ken, Japan, 650-0047
      • Research Site
  • Kagawa-Ken
    • Kita-gun, Kagawa-Ken, Japan, 761-0793
      • Research Site
  • Kyoto-Fu
    • Kyoto-shi, Kyoto-Fu, Japan, 616-8255
      • Research Site
    • Kyoto-shi, Kyoto-Fu, Japan, 607-8113
      • Research Site
  • Mie-Ken
    • Tsu-shi, Mie-Ken, Japan, 514-8507
      • Research Site
  • Nagasaki-Ken
    • Nishisonogi, Nagasaki-Ken, Japan, 851-2103
      • Research Site
  • Oita-Ken
    • Yufu-shi, Oita-Ken, Japan, 879-5593
      • Research Site
  • Okayama-Ken
    • Kurashiki-shi, Okayama-Ken, Japan, 710-0813
      • Research Site
    • Okayama-shi, Okayama-Ken, Japan, 703-8265
      • Research Site
    • Tsukuba-gun, Okayama-Ken, Japan, 701-0304
      • Research Site
  • Osaka-Fu
    • Kishiwada-shi, Osaka-Fu, Japan, 596-8522
      • Research Site
    • Osaka-shi, Osaka-Fu, Japan, 545-8586
      • Research Site
    • Osaka-shi, Osaka-Fu, Japan, 530-0001
      • 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
  • Shizuoka-Ken
    • 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
      • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1081 GM
    • Alzheimer Research Center
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medisch Centrum
• Poland
  • Bialystok, Poland, 15-732
    • Podlaskie Centrum Psychogeriatrii
  • Bydgoszcz, Poland, 85-796
    • PALLMED Sp. z o.o.
  • Gdansk, Poland
    • Uniwersyteckie Centrum Kliniczne
  • Katowice, Poland, 40-650
    • Novo-Med Zielinski i wspolnicy Sp. j.
  • Lodz, Poland, 92-216
    • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
  • Lubin, Poland, 59-300
    • Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.
  • Lublin, Poland, 20-950
    • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Plewiska, Poland, 62-064
    • Neurologiczny NZOZ Centrum Leczenia SM
  • Poznan, Poland, 61-853
    • NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne Medyk
  • Slaskie, Poland, 41-100
    • Neuro-Care Gabriela Klodowska
  • Sopot, Poland, 81-855
    • NZOZ "SENIOR" Poradnia Psychogeriatryczna
  • Szczecin, Poland, 70-111
    • Osrodek Badan Klinicznych Euromedis
  • Warszawa, Poland, 01-697
    • mMED Maciej Czarnecki
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 8907
    • Hospital Universitari de Bellvitge
  • Barcelona, Spain, 08028
    • Hospital Universitari Quiron Dexeus
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Alicante
    • Elche, Alicante, Spain, 3203
      • Hospital General Universitario de Elche
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • Althaia Hospital Sant Joan de Deu
  • Córdoba
    • Cordoba, Córdoba, Spain, 14011
      • Hospital Universitario Reina Sofia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
• Sweden
  • Malmö, Sweden, 20502
    • Skånes Universitetssjukhus, Malmo
  • Mölndal, Sweden, 43141
    • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
  • Stockholm, Sweden, 14186
    • Karolinska Universitetssjukhuset, Huddinge
  • Uppsala, Sweden, 75185
    • Akademiska Sjukhuset
• Switzerland
  • Basel, Switzerland, 4025
    • Universitären Psychiatrischen Kliniken Basel (UPK)
  • Biel/Bienne, Switzerland, 2502
    • Medizinisches Zentrum MZB Biel
  • Geneve 14, Switzerland, 1211
    • Hôpitaux Universitaires de Genève - HUG
  • Lausanne, Switzerland, CH-1011
    • Centre Hospitalier Universitaire Vaudois
  • Lugano, Switzerland, 6903
    • Ospedale Civico
  • Schlieren, Switzerland, 8952
    • Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Phoenix, Arizona, United States, 85013
      • Xenoscience Inc.
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Institute
  • California
    • Irvine, California, United States, 92607
      • Institute for Memory Impairments
    • Long Beach, California, United States, 85013
      • Renewal Behavioral Health
    • Los Angeles, California, United States, 90033
      • USC Keck School of Medicine
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Oxnard, California, United States, 93030
      • Pacific Neuroscience Medical Group
    • Redlands, California, United States, 92354
      • Anderson Clinical Research
    • San Diego, California, United States, 92103
      • Pacific Research Network
    • San Diego, California, United States, 92103
      • University of California San Diego Medical Center
    • San Francisco, California, United States, 94114
      • California Pacific Medical Center
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Santa Rosa, California, United States, 95403
      • St Joseph Heritage Healthcare
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Thornton, Colorado, United States, 80233
      • IMMUNOe International Research Centers
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern Connecticut, PC
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies, Inc.
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center, Inc.
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Deerfield Beach, Florida, United States, 33064
      • Quantum Laboratories Inc.
    • Hollywood, Florida, United States, 33021
      • Infinity Clinical Research, LLC
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University Cognitive Neurology Clinic & ADRC
    • Columbus, Georgia, United States, 31909
      • Medical Research Health and Education Foundation, Inc
    • Decatur, Georgia, United States, 30033
      • NeuroStudies.net, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Josephson, Wallack, Munshower Neurology, PC
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
    • Newton, Massachusetts, United States, 05201
      • Boston Center for Memory
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic, PA
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices & Research
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • AdvanceMed Research
  • New York
    • Latham, New York, United States, 12110
      • Empire Neurology, PC
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10021
      • Weill Cornell Medical College-New York Presbyterian Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest Baptist Health
  • Ohio
    • Dublin, Ohio, United States, 43017
      • Ohio State University Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research, LLC
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Memory Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • North Charleston, South Carolina, United States, 29406-6076
      • Roper St. Francis Healthcare
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adult Specialty Research
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Clinical Neuroscience Research Association, Inc
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Spokane, Washington, United States, 99202
      • Northwest Neurological, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose; Monthly intravenous (IV) infusions	Drug: Placebo; Placebo; Drug: Aducanumab (BIIB037); Low dose; Drug: Aducanumab (BIIB037); High dose
Experimental: High Dose; Monthly intravenous (IV) infusions	Drug: Placebo; Placebo; Drug: Aducanumab (BIIB037); Low dose; Drug: Aducanumab (BIIB037); High dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78	CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.	Baseline, Week 78

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78	The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.	Baseline, Week 78
Change From Baseline in Mini Mental State Examination (MMSE) Score at Week 78	The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.	Baseline, Week 78
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) at Week 78	ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.	Baseline, Week 78

Collaborators and Investigators

• Sponsor: Biogen

Publications and helpful links

General Publications

• Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2022 Jan 1;79(1):13-21. doi: 10.1001/jamaneurol.2021.4161.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2015
• Primary Completion (Actual): August 5, 2019
• Study Completion (Actual): August 5, 2019

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: BIIB037; Aducanumab
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 221AD302; 2015-000967-15 (EudraCT Number)