A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease (ENVISION)

April 4, 2025 updated by: Biogen

A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1027

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
      • Macquarie Park, New South Wales, Australia, 2113
        • KaRa Institute of Neurological Diseases
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Australian Alzheimer's Research Foundation
  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Kortrijk, Belgium, 8500
        • Az Groeninge
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • UZ Leuven
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 81210-310
        • Instituto de Neurologia de Curitiba - Hospital Ecoville
      • Curitiba, Paraná, Brazil, 80240-280
        • Trial Tech Tecnologia em Pesquisas com Medicamentos Ltda
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Instituto do Cerebro do Rio Grande do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-000
        • IMV Pesquisa Neurologica Sociedade Simples Ltda
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403-010
        • IPq-HCFMUSP - Instituto de Psiquiatria do Hospital das Clínicas da FMUSP
  • Canada
      • Quebec, Canada, G1J1Z4
        • CHU de Quebec- Hopital de l Enfant Jesus
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary - Heritage Medical Research Clinic
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • UBC Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1N2
        • Centricity Research Halifax
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Centre - Redefining Healthy Aging
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program (Neurology Research Inc.)
      • Toronto, Ontario, Canada, M6A 2E1
        • Baycrest Centre for Geriatric Care
      • Toronto, Ontario, Canada, M4G 3E8
        • Centricity Research Toronto LMC
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Clinique de la Memoire de l'Outaouais
      • Greenfield-Park, Quebec, Canada, J4V 2J2
        • MoCA Research and Innovation Inc
      • Montréal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Institute Clinical Research Unit
  • Finland
      • Helsinki, Finland, 00100
        • Terveystalo Ruoholahti
      • Turku, Finland, 20520
        • CRST, Clinical Research Services Turku
  • France
      • Paris, France, 75013
        • Hopital Broca
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
    • Bas Rhin
      • Strasbourg Cedex, Bas Rhin, France, 67000
        • CHU Strasbourg - Hôpital Hautepierre
    • Bouches-du-Rhône
      • Marseille cedex 05, Bouches-du-Rhône, France, 13385
        • Hopital de la Timone
    • Gironde
      • Bordeaux Cedex, Gironde, France, 33076
        • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
    • Haute Garonne
      • Toulouse Cedex 9, Haute Garonne, France, 31059
        • Hôpital La Grave
    • Herault
      • Montpellier, Herault, France, 34295
        • Hopital Gui de Chauliac
    • Ille Et Vilaine
      • Rennes cedex 9, Ille Et Vilaine, France, 35033
        • CHU Rennes - Pontchaillou
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44800
        • CHU Nantes - Hopital Nord Laënnec
    • Nord
      • Lille Cedex, Nord, France, 59037
        • Hopital Roger Salengro - CHU Lille
    • Paris
      • Paris cedex 10, Paris, France, 75010
        • Hopital Lariboisiere
    • Rhone
      • Villeurbanne, Rhone, France, 69100
        • Hôpital des Chapennes
  • Germany
      • Berlin, Germany, 13125
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 12099
        • NEUROZENTRUM tempelhof.berlin
    • Baden Wuerttemberg
      • Freiburg, Baden Wuerttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg
      • Mannheim, Baden Wuerttemberg, Germany, 68165
        • ISPG - Institut fuer Studien zur Psychischen Gesundheit
      • Tuebingen, Baden Wuerttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen
    • Bayern
      • Bayreuth, Bayern, Germany, 95445
        • Klinikum Bayreuth GmbH- Hohe Warte
      • Muenchen, Bayern, Germany, 81675
        • Klinikum rechts der Isar der TU Muenchen
      • Muenchen, Bayern, Germany, 81377
        • Institut fuer Schlaganfall- und Demenzforschung (ISD)
    • Hessen
      • Bad Homburg, Hessen, Germany, 61350
        • Zentrum für klinische Forschung Dr.med. Irma Schöll
      • Frankfurt, Hessen, Germany, 60528
        • Universitaetsklinikum Frankfurt Goethe-Universitaet
    • Mecklenburg Vorpommern
      • Greifswald, Mecklenburg Vorpommern, Germany, 17475
        • Universitaetsmedizin Greifswald
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • Universitaetsmedizin Goettingen
    • Nordrhein Westfalen
      • Bochum, Nordrhein Westfalen, Germany, 44791
        • Katholisches Klinikum Bochum gGmbH
      • Bonn, Nordrhein Westfalen, Germany, 53127
        • Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)
      • Duesseldorf, Nordrhein Westfalen, Germany, 40225
        • Universitaetsklinikum Duesseldorf AoeR
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Universitaetsklinikum Koeln
    • Sachsen
      • Dresden, Sachsen, Germany, 1307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
    • Sachsen Anhalt
      • Magdeburg, Sachsen Anhalt, Germany, 39120
        • Universitaetsklinikum Magdeburg
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Genova, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Napoli, Italy, 80138
        • Azienda Ospedaliera Universitaria- Università Degli Studi Della Campania "Luigi Vanvitelli"
      • Perugia, Italy, 6156
        • Azienda Ospedaliera e Universitaria di Perugia
      • Roma, Italy, 00179
        • Fondazione Santa Lucia IRCCS
      • Roma, Italy, 00185
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
      • Salerno, Italy, 84131
        • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Azienda Ospedaliera Card. G. Panico
    • Milano
      • Monza, Milano, Italy, 20052
        • Asst Di Monza
    • Palermo
      • Cefalù, Palermo, Italy, 90015
        • Fondazione Istituto G.Giglio di Cefalù
    • Vicenza
      • Arzignano VI, Vicenza, Italy, 36071
        • Ospedale di Arzignano
  • Japan
    • Aichi-Ken
      • Obu-shi, Aichi-Ken, Japan, 474-8511
        • National Center for Geriatrics and Gerontology
    • Chiba-Ken
      • Chiba-shi, Chiba-Ken, Japan, 263-0043
        • Inage Neurology and Memory Clinic
      • Chiba-shi, Chiba-Ken, Japan, 260-8656
        • Hakuyokai Kashiwado Hospital
    • Fukushima-Ken
      • Koriyama-shi, Fukushima-Ken, Japan, 963-8563
        • Southern TOHOKU Medical Clinic
    • Hiroshima-Ken
      • Otake-shi, Hiroshima-Ken, Japan, 739-0696
        • NHO Hiroshima-Nishi Medical Center
    • Hyogo-Ken
      • Himeji-shi, Hyogo-Ken, Japan, 672-8043
        • Himeji Central Hospital Clinic
    • Kagawa-Ken
      • Kita-gun, Kagawa-Ken, Japan, 761-0793
        • Kagawa University Hospital
    • Kanagawa-Ken
      • Atsugi-shi, Kanagawa-Ken, Japan, 243-8551
        • Tokushukai Shonan Atsugi Hospital
      • Kamakura-shi, Kanagawa-Ken, Japan, 247-8533
        • Tokushukai Shonan Kamakura General Hospital
      • Kawasaki-shi, Kanagawa-Ken, Japan, 213-8507
        • Teikyo University Hospital, Mizonokuchi
    • Kyoto-Fu
      • Kyoto-shi, Kyoto-Fu, Japan, 607-8113
        • Rakuwakai Otowa Rehabilitation Hospital
      • Kyoto-shi, Kyoto-Fu, Japan, 616-8255
        • NHO Utano National Hospital
    • Okayama-Ken
      • Kurashiki-shi, Okayama-Ken, Japan, 710-0813
        • Katayama Medical Clinic
    • Osaka-Fu
      • Kishiwada-shi, Osaka-Fu, Japan, 596-0042
        • Tokushukai Kishiwada Tokushukai Hospital
      • Suita-shi, Osaka-Fu, Japan, 565-0871
        • Osaka University Hospital
    • Saitama-Ken
      • Kasukabe-shi, Saitama-Ken, Japan, 344-0036
        • Midorikai Takesato Hospital
    • Tokyo-To
      • Bunkyo-ku, Tokyo-To, Japan, 113-0034
        • Memory Clinic Ochanomizu
      • Kodaira-shi, Tokyo-To, Japan, 187-8551
        • National Center of Neurology and Psychiatry
    • Yamagata-Ken
      • Yamagata-shi, Yamagata-Ken, Japan, 990-0834
        • Tokushukai Yamagata Tokushukai Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 5505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 5030
        • Konkuk University Medical Center
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
  • Mexico
    • Distrito Federal
      • Ciudad de México, Distrito Federal, Mexico, 3103
        • Health Pharma Professional Research S.A. de C.V.
    • Jalisco
      • Guadalara, Jalisco, Mexico, 44610
        • Hospital Mexico Americano SC
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio González
      • Monterrey, Nuevo León, Mexico, 64620
        • Centro de Estudios Clinicos y Especialidades Medicas, S.C.
      • Monterrey, Nuevo León, Mexico, 64710
        • AVIX Investigación Clínica S.C
  • Poland
      • Lublin, Poland, 20-090
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Kliniczny Oddział Neurologii Oddział Udarowy
      • Wroclaw, Poland, 53659
        • NZOZ Wroclawskie Centrum Alzheimerowskie
    • Kujawsko-Pomorskie Województwo
      • Bydgoszcz, Kujawsko-Pomorskie Województwo, Poland, 85-133
        • PROMENTE Sp. z o.o.
    • Mazowieckie Województwo
      • Warszawa, Mazowieckie Województwo, Poland, 01-684
        • Centrum Medyczne NeuroProtect
    • Podkarpackie Wojewódctwo
      • Bialystok, Podkarpackie Wojewódctwo, Poland, 15-756
        • Podlaskie Centrum Psychogeriatrii
    • Pomorskie Województwo
      • Sopot, Pomorskie Województwo, Poland, 81-855
        • Centrum Medyczne Senior
    • Śląskie Województwo
      • Katowice, Śląskie Województwo, Poland, 40-650
        • Nzoz Novo-Med
      • Siemianowice Slaskie, Śląskie Województwo, Poland, 41-100
        • Neuro-Care Gabriela Klodowska
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08028
        • Fundació ACE
      • Lleida, Spain, 25198
        • Hospital Universitari de Santa Maria
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra (MAD)
      • Sevilla, Spain, 41009
        • Hospital Victoria Eugenia
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
    • Córdoba
      • Cordoba, Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofía
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20009
        • Policlinica Gipuzkoa
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska Universitetssjukhuset
    • Scania
      • Malmö, Scania, Sweden, 205 02
        • Skane University Hospital
    • Västra Götaland
      • Mölndal, Västra Götaland, Sweden, 43180
        • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
  • United Kingdom
      • Bristol, United Kingdom, BS32 4SY
        • Re Cognition Health Bristol
    • East Lothian
      • Edinburgh, East Lothian, United Kingdom, EH8 9YL
        • The University of Edinburgh
    • Greater London
      • London, Greater London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, Greater London, United Kingdom, SE5 8AF
        • Institute of Psychiatry, Psychology and Neuroscience
      • London, Greater London, United Kingdom, W1G 9RU
        • Re:Cognition Health Ltd (London)
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, MR8 5RB
        • Park House
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Southampton, Hampshire, United Kingdom, SO30 3JB
        • Moorgreen Hospital
    • Lothian Region
      • Edinburgh, Lothian Region, United Kingdom, EH12 9DQ
        • Brain Health Scotland Life Sciences
    • Somerset
      • Bath, Somerset, United Kingdom, BA1 3NG
        • The RICE Centre
    • Strathclyde
      • Motherwell, Strathclyde, United Kingdom, ML1 4UF
        • Glasgow Memory Clinic Ltd
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Gilbert Neurology Partners, PLLC
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
      • Phoenix, Arizona, United States, 85004
        • Xenoscience Inc.
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
      • Scottsdale, Arizona, United States, 85251
        • HonorHealth Neurology
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
      • Tucson, Arizona, United States, 85012
        • Banner Alzheimer's Institute
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Health Initiatives Research
    • California
      • El Centro, California, United States, 92243
        • Sun Valley Behaivoral Med Center
      • Fresno, California, United States, 93710
        • Neuropain Medical Center
      • Fullerton, California, United States, 92835
        • Neurology Center of North Orange County
      • Irvine, California, United States, 92614
        • Irvine Center for Clinical Research, Inc.
      • Los Angeles, California, United States, 90095
        • Mary S. Easton Center for Alzheimer's Disease Research, UCLA
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System
      • Palo Alto, California, United States, 94304
        • Stanford Hospital and Clinics
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
      • San Francisco, California, United States, 94115
        • Sutter Health-San Francisco
      • San Francisco, California, United States, 94143
        • University of California San Francisco (PARENT)
      • San Marcos, California, United States, 92069
        • The Neuron Clinic
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research, LLC
      • Temecula, California, United States, 92591
        • Viking Clinical Research Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
      • Basalt, Colorado, United States, 81621
        • Mountain Neurological Research Center
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Yale University
      • New Haven, Connecticut, United States, 06511
        • Yale University School of Medicine
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders (IND)
      • Norwalk, Connecticut, United States, 06851
        • Research Center for Clinical Studies, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20060-0002
        • Howard University Health Sciences
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Neurology of Central Florida Research Center, LLC
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Boca Raton, Florida, United States, 33486
        • ECommunity Research, LLC
      • Boca Raton, Florida, United States, 33428
        • Neurology Offices of South Florida, PLLC
      • Bradenton, Florida, United States, 34209
        • Nova Clinical Research, LLC
      • Cutler Bay, Florida, United States, 45417
        • JY Research Institute
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Hollywood, Florida, United States, 33024
        • Infinity Clinical Research, LLC
      • Lady Lake, Florida, United States, 32159
        • Charter Research, LLC
      • Lakeland, Florida, United States, 33803
        • ARS - Lake Oconee
      • Miami, Florida, United States, 33165
        • Medical Research Center
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Ocoee, Florida, United States, 34761
        • K2 Medical Research, Llc
      • Orlando, Florida, United States, 32751
        • K2 Medical Research
      • Orlando, Florida, United States, 32751
        • K2 Medical Research, Llc
      • Orlando, Florida, United States, 32819
        • Headlands Research LLC
      • Orlando, Florida, United States, 32832
        • Conquest Research
      • Pompano Beach, Florida, United States, 33064
        • Quantum Laboratories Inc.
      • Port Orange, Florida, United States, 32127
        • United Medical Research
      • Stuart, Florida, United States, 34997
        • Brain Matters Research
      • Tampa, Florida, United States, 33613
        • USF Health Byrd Institute
      • Tampa, Florida, United States, 33607
        • K2 Medical Research Tampa
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Pacific Neuroscience
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60637
        • Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Center - Neuroscience Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Kansas
      • Fairway, Kansas, United States, 66205
        • University of Kansas Medical Center Research Institute, Inc.
      • Wichita, Kansas, United States, 67214
        • Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health System PARENT
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115-5804
        • Brigham and Women's Hospital Department of Neurology
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices and Research
      • Newton, Massachusetts, United States, 02459
        • Boston Center for Memory
      • Plymouth, Massachusetts, United States, 02360
        • Donald S. Marks, M.D., P.C.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University - Detroit Medical Center
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Institute for Neurological Disorders
    • Minnesota
      • Saint Paul, Minnesota, United States, 55130
        • Center for Memory and Aging
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic, PA
    • Missouri
      • Ozark, Missouri, United States, 65721
        • Sharlin Health and Neurology
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3285
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic Lou Ruvo Center for Brain Health
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • The Cognitive Research Center of New Jersey
      • Toms River, New Jersey, United States, 08755
        • CenExel Advanced Memory Research Institute of NJ
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany, PC
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Institute (SPRI)
      • New York, New York, United States, 10029
        • Mount Sinai
      • New York, New York, United States, 10016
        • New York University Medical Center PRIME
      • Patchogue, New York, United States, 11772
        • South Shore Neurologic Associates, P.C.
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
      • Rochester, New York, United States, 14642
        • University of Rochester - PARENT
      • Staten Island, New York, United States, 10314
        • Richmond Behavioral Associates ERG Clinical Research - New York PLLC
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Tarrytown, New York, United States, 10591
        • IMA Evaluations LLC
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Matthews, North Carolina, United States, 28105
        • AMC Research, LLC
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health Sciences
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • North Canton, Ohio, United States, 44720
        • Neuro-Behavioral Clinical Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Tulsa, Oklahoma, United States, 74136
        • Central States Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University (OHSU)
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associates, LTD
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Memory Center
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Rhode Island Mood & Memory Research Institute
      • East Providence, Rhode Island, United States, 02915-2237
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • South Carolina
      • Port Royal, South Carolina, United States, 29935
        • Coastal Neurology PA
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic, PC
      • Knoxville, Tennessee, United States, 37909
        • Genesis Neuroscience Clinic
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adult Specialty Research
      • Brownsville, Texas, United States, 78526
        • Headlands Research - Brownsville
      • Dallas, Texas, United States, 75231
        • Kerwin Medical Center
      • Dallas, Texas, United States, 75390-8896
        • UT Southwestern Medical Center
      • Fort Worth, Texas, United States, 76107
        • University of North Texas Health Science Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
      • Houston, Texas, United States, 77074
        • Clinical Trial Network LLC
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology Consultants
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System
      • Norfolk, Virginia, United States, 23510
        • Glennan Center for Geriatrics and Gerontology
      • Richmond, Virginia, United States, 23294
        • National Clinical Research Inc. - Richmond
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington Medical Center
      • Spokane, Washington, United States, 99202
        • Kingfisher Cooperative, LLC
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin-Madison
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET
  • Must have a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
  • The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time

  • Must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria

    1. Have an MMSE score between 22 and 30 inclusive
    2. Have a CDR memory score >0.5
    3. Have a Clinical Dementia Rating Scale Global Score (CDR-GS) of 0.5 or 1.0
    4. Have a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score of 85 or lower indicative of objective cognitive impairment
  • Apart from a clinical diagnosis of early Alzheimer's disease, the participant must be in good health as determined by the Investigator based on medical history and screening assessments
  • Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers)

Key Exclusion Criteria:

  • Any uncontrolled medical or neurological/neurodegenerative condition (other than Alzheimer's disease) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment
  • Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening
  • Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
  • History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product
  • Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to Screening unless documentation of receipt of placebo is available
  • Current use or previous use of medications with a purported disease-modifying effect in Alzheimer's disease, outside of investigational studies
  • Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures
  • Use of any investigational drug
  • Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab.)
  • A negative PET scan result with any amyloid-targeting ligand within 12 months prior to Screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo, monthly (once every four weeks), administered as IV infusion.
Drug: Placebo
Administered as specified in the treatment arm.
Experimental: Aducanumab
Participants will receive aducanumab, up to 10 milligrams per kilogram (mg/kg), monthly (once every four weeks), administered as intravenous (IV) infusion.
Drug: Aducanumab
Administered as specified in the treatment arm.
Other Names:
  • BIIB037
  • Aducanumab-avwa
  • Aduhelm

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
Time Frame: Baseline, Week 78
The Clinical Dementia Rate Scale integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following the caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. A positive change from baseline indicates greater impairment.
Baseline, Week 78

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106
Time Frame: Baseline, Weeks 78 and 106
The iADRS composite captures a decline in both cognition and daily function. It is a simple linear combination of the Alzheimer's disease assessment scale, cognitive subscale (ADAS-Cog13), and the Alzheimer's disease cooperative study scale for activities of daily living in mild cognitive impairment (ADCS-ADL-MCI). The ADAS-Cog13 scale ranges from 0 to 85 (higher scores indicate worse performance) and the ADCS-ADL-MCI scale ranges from 0 to 53 (higher scores indicate greater independent, healthy functioning). The total score for iADRS scale ranges from 0 to 138, where higher scores indicate better performance.
Baseline, Weeks 78 and 106
Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106
Time Frame: Baseline, Weeks 78 and 106
The ADCS-ADL-MCI scale consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances, etc) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the participant'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. Higher scores indicate greater independent, healthy functioning. A positive change from baseline indicates healthy functioning while a negative change from baseline indicates a decline in independent functioning.
Baseline, Weeks 78 and 106
Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106
Time Frame: Baseline, Weeks 78 and 106
ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The cognitive subscale 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. Higher scores indicate worse performance. A positive change from baseline indicates decline in cognitive performance.
Baseline, Weeks 78 and 106
Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106
Time Frame: Baseline, Weeks 78 and 106
The MMSE scale is a 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. Higher scores indicate better performance. A negative change from baseline indicates decline in cognitive performance.
Baseline, Weeks 78 and 106
Change From Baseline in Neuropsychiatric Inventory-10 (NPI-10) Score at Weeks 78 and 106
Time Frame: Baseline, Weeks 78 and 106
The NPI-10 is a questionnaire administered to the informant, designed to obtain information on the presence of neuropsychiatric symptoms and behaviors in a participant with Alzheimer's disease. Ten areas are assessed: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability and aberrant motor behavior. The NPI total score ranges from 0 to 120. Higher scores indicate greater impairment. A negative change from baseline indicates improvement (symptom reduction).
Baseline, Weeks 78 and 106
Change From Baseline in Amyloid Positron Emission Tomography (PET) Signal at Weeks 78 and 104
Time Frame: Baseline, Weeks 78 and 104
Amyloid PET scan assesses cerebral amyloid load using radiotracers which is standardized into centiloids. Centiloid values on centiloid scale is based on mean composite standardized uptake value ratio (SUVR).
Baseline, Weeks 78 and 104
Change From Baseline in Tau PET Signal at Weeks 78 and 104
Time Frame: Baseline, Weeks 78 and 104
The cerebral tau level was measured by tau PET imaging. Tau PET imaging was conducted using radiotracer. SUVR is a ratio of PET uptake measured in brain region of interest and a disease-free reference region. A higher SUVR is an indication of increased PET radiotracer uptake and worsening disease.
Baseline, Weeks 78 and 104
Change From Baseline in CDR-SB Score at Week 106
Time Frame: Baseline, Week 106
The CDR 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 participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The CDR-SB sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. Positive change from baseline indicates greater impairment.
Baseline, Week 106
Change From Baseline in Global Statistical Test (GST) Composite Z-Score at Weeks 78 and 106
Time Frame: Baseline, Weeks 78 and 106
GST z-score is an average of z-scores of CDR-SB, ADASCog13 and ADCS-ADL-MCI. CDR-SB assesses 3 cognitive (memory,orientation, judgment/problem-solving)and 3 functional(community affairs,home/hobbies,personal care) domains. Sum of Boxes method combines scores across 6 domains, ranging from 0-18(higher scores=greater impairment). ADAS-Cog13 evaluates cognitive tasks like word recall, naming, orientation and memory, with scores from 0-85 (higher scores=worse performance). ADCS-ADL-MCI rates 17 tasks (e.g.,shopping, preparing meal) and 1 basic task(dressing) with scores from 0-53 (higher scores=greater independence/healthy functioning). z-score>0 indicates greater impairment/worse performance for CDR-SB and ADASCog13 scales and improved functioning for ADCS-ADL-MCI. For ADCS-ADL-MCI, z-score were reversed (new reversed value=original value-1) to make interpretation consistent. The GST z-score of 0 indicates population mean and score>0 indicate greater impairment/worse performance.
Baseline, Weeks 78 and 106

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2022

Primary Completion (Actual)

August 12, 2024

Study Completion (Actual)

August 12, 2024

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221AD305
  • 2022-001671-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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