A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

January 31, 2025 updated by: Biogen

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1696

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
      • Chermside, New South Wales, Australia, 4032
        • The Prince Charles Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
      • Erina, New South Wales, Australia, 2250
        • Central Coast Neurosciences Research (Erina)
      • Macquarie Park, New South Wales, Australia, 2113
        • KaRa Institute of Neurological Diseases
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Health
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Australian Alzheimer's Research Foundation
  • Austria
      • Graz, Austria, 8036
        • Lkh - Universitaetsklinikum Graz
      • Salzburg, Austria, 5020
        • Christian-Doppler-Klinik - Universitätsklinikum Salzburg
      • Vienna, Austria, 1090
        • Akh - Medizinische Universität Wien
  • Belgium
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brugge, Belgium, 8000
        • AZ Sint-Jan
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Canada
      • Quebec, Canada, G1J 1Z4
        • CHU de Quebec - Hôpital de l' Enfant Jésus
    • Alberta
      • Calgary, Alberta, Canada, T2N4Z6
        • University of Calgary - Heritage Medical Research Clinic
    • British Columbia
      • Kamloops, British Columbia, Canada, V2C 5T1
        • The Medical Arts Health Research Group
      • Penticton, British Columbia, Canada, V2A 5L5
        • The Medical Arts Health Research Group
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • UBC Hospital
      • West Vancouver, British Columbia, Canada, V7T 1C5
        • Medical Arts Health Research Group
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1M7
        • True North Clinical Research - Halifax Inc.
      • Kentville, Nova Scotia, Canada, MB3 2S7
        • True North Clinical Research
    • Ontario
      • London, Ontario, Canada, N6C OA7
        • St. Joseph's HC- Parkwood Institute
      • Ottawa, Ontario, Canada, K1N 5C8
        • Bruyère Continuing Care
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Centre - Redefining Healthy Aging
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Hospital
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program (Neurology Research Inc.)
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Clinique de la Memoire de l'Outaouais
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Institut et Clinique MoCA
      • Montréal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Institute Clinical Research Unit
  • Denmark
      • Aalborg, Denmark, 9000
        • CCBR - Ålborg - DK
      • København, Denmark, 2100
        • Danish Dementia Research Centre
      • Vejle, Denmark, 7100
        • CCBR - Vejle - DK
  • Finland
      • Helsinki, Finland, 00180
        • Terveystalo Ruoholahti
      • Kuopio, Finland, 70210
        • Itä-Suomen yliopisto, Aivotutkimusyksikkö
      • 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, 67098
        • CHU Strasbourg - Hôpital Hautepierre
    • Bouches-du-Rhône
      • Marseille cedex 05, Bouches-du-Rhône, France, 13385
        • Hôpital 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
      • Toulouse cedex 9, Haute Garonne, France, 31059
        • Hopital Purpan
    • 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
      • Nantes cedex 1, Loire Atlantique, France, 44093
        • CHU Nantes - Hopital Nord Laënnec
    • Marne
      • Reims, Marne, France, 51092
        • CHU Reims - Hôpital Maison Blanche
    • Nord
      • Lille Cedex, Nord, France, 59037
        • CHU Lille - Hôpital Roger Salengro
    • Paris
      • Paris cedex 10, Paris, France, 75010
        • Hôpital Lariboisière
    • Rhone
      • Bron Cedex, Rhone, France, 69677
        • CHU de Lyon - Hopital Neurologique Pierre Wertheimer
      • Villeurbanne, Rhone, France, 69100
        • Hôpital des Chapennes
  • Germany
      • Berlin, Germany, 10629
        • emovis GmbH
      • Berlin, Germany, 12099
        • Neurologie im Tempelhofer Hafen
      • Berlin, Germany, 13125
        • Charite Universitaetsmedizin Berlin - Campus Berlin Buch
    • Baden Wuerttemberg
      • Böblingen, Baden Wuerttemberg, Germany, 71034
        • Studienzentrum für Neurologie und Psychiatrie
      • Mannheim, Baden Wuerttemberg, Germany, 68165
        • ISPG - Institut fuer Studien zur Psychischen Gesundheit
      • Stuttgart, Baden Wuerttemberg, Germany, 70182
        • mind mvz GmbH
      • Ulm, Baden Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm
      • Ulm, Baden Wuerttemberg, Germany, 89073
        • Neuropoint Studienzentrum
    • Bayern
      • Bayreuth, Bayern, Germany, 95445
        • Klinikum Bayreuth GmbH- Hohe Warte
      • Günzburg, Bayern, Germany, 89312
        • Bezirkskrankenhaus Guenzburg
      • Munich, Bayern, Germany, 81675
        • Klinikum rechts der Isar der TU Muenchen
      • München, Bayern, Germany, 81377
        • Institut fuer Schlaganfall- und Demenzforschung (ISD)
      • Unterhaching, Bayern, Germany, 82008
        • Neuropraxis Muenchen Sued
    • Hessen
      • Erbach, Hessen, Germany, 64711
        • Neuro Centrum Science GmbH, Geschaftführende Gesellschafterin Barbara Unsorg und Prüfarzt Dr. med. G
      • Kassel, Hessen, Germany, 34121
        • Neurologische Gemeinschaftspraxis Kassel
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • Klinische Forschung Hannover-Mitte GmbH
    • Nordrhein Westfalen
      • Aachen, Nordrhein Westfalen, Germany, 52074
        • Universitaetsklinikum Aachen AOeR
      • Bielefeld, Nordrhein Westfalen, Germany, 33647
        • Neurozentrum Bielefeld
      • Duesseldorf, Nordrhein Westfalen, Germany, 40225
        • Universitaetsklinikum Duesseldorf AoeR
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Universitaetsklinikum Koeln
      • Siegen, Nordrhein Westfalen, Germany, 57076
        • Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
    • Thueringen
      • Altenburg, Thueringen, Germany, 04600
        • Klinikum Altenburger Land GmbH
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Genova, Italy, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Napoli, Italy, 80138
        • AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
      • Perugia, Italy, 06156
        • Azienda Ospedaliera e Universitaria di Perugia
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italy, 00161
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
      • Roma, Italy, 179
        • Fondazione Santa Lucia IRCCS
      • Salerno, Italy, 84131
        • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
      • Siena, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
    • 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
    • Palermo
      • Cefalù, Palermo, Italy, 90015
        • Fondazione Istituto G.Giglio di Cefalù
  • Japan
    • Aichi-Ken
      • Obu-shi, Aichi-Ken, Japan, 474-8511
        • Research Site
    • Chiba-Ken
      • Chiba-shi, Chiba-Ken, Japan, 260-8656
        • Research Site
      • Chiba-shi, Chiba-Ken, Japan, 263-0043
        • Research Site
      • Inzai-shi, Chiba-Ken, Japan, 270-1694
        • 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
    • Fukushima-Ken
      • Aizu-Wakamatsu, Fukushima-Ken, Japan, 965-8585
        • Research Site
    • Hiroshima-Ken
      • Otake-shi, Hiroshima-Ken, Japan, 739-0696
        • Research Site
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070-8644
        • Research Site
      • Sapporo-shi, Hokkaido, Japan, 064-8570
        • 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
    • Kanagawa-Ken
      • Kamakura-shi, Kanagawa-Ken, Japan, 247-8533
        • 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
      • Togitsu, Nagasaki-Ken, Japan, 851-2103
        • Research Site
    • Niigata-Ken
      • Nagaoka-shi, Niigata-Ken, Japan, 940-2081
        • Research Site
    • Oita-Ken
      • Yufu-shi, Oita-Ken, Japan, 879-5593
        • Research Site
    • Okayama-Ken
      • Kurashiki-shi, Okayama-Ken, Japan, 247-8533
        • Research Site
      • Okayama-shi, Okayama-Ken, Japan, 703-8265
        • Research Site
      • Tsukuba, Okayama-Ken, Japan, 701-0304
        • Research Site
    • Osaka-Fu
      • Osaka-shi, Osaka-Fu, Japan, 545-8586
        • Research Site
      • Suita-shi, Osaka-Fu, Japan, 565-0871
        • Research Site
    • Saitama-Ken
      • Iruma-gun, Saitama-Ken, Japan, 350-0495
        • Research Site
      • Kasukabe-shi, Saitama-Ken, Japan, 344-0036
        • Research Site
    • Shizuoka-Ken
      • Shizuka-shi, Shizuoka-Ken, Japan, 424-8636
        • Research Site
      • Shizuoka-shi, Shizuoka-Ken, Japan, 420-8688
        • Research Site
    • Tokyo-To
      • Bunkyo-ku, Tokyo-To, Japan, 113-0034
        • Research Site
      • Kiyose-shi, Tokyo-To, Japan, 204-8585
        • Research Site
      • Kodaira-shi, Tokyo-To, Japan, 187-8551
        • Research Site
    • Yamagata-Ken
      • Yamagata-shi, Yamagata-Ken, Japan, 990-0834
        • Research Site
  • Korea, Republic of
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
    • Gyeonggi-do
      • Incheon, Gyeonggi-do, Korea, Republic of, 22332
        • Inha University Hospital
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1081 GN
        • Brain Research Center
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis, Molengracht
      • Rotterdam, Netherlands, 3015 AA
        • Erasmus Medisch Centrum
  • Poland
      • Bialystok, Poland, 15-756
        • Podlaskie Centrum Psychogeriatrii
      • Bydgoszcz, Poland, 85-023
        • PALLMED Sp. z o.o.
      • Gdansk, Poland, 80-952
        • Klinika Psychiatrii Doroslych UCK
      • Katowice, Poland, 40-650
        • Novo-Med Zielinski I Wspolnicy Sp. J.
      • Lodz, Poland, 92-216
        • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
      • Lublin, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Poznan, Poland, 61-853
        • NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
      • Siemianowice Slaskie, Poland, 41-100
        • Neuro-Care Gabriela Klodowska
      • Sopot, Poland, 81-855
        • Centrum Medyczne SENIOR
      • Szczecin, Poland, 70-111
        • Osrodek Badan Klinicznych Euromedis
      • Warszawa, Poland, 01-684
        • Centrum Medyczne NeuroProtect
      • Wroclaw, Poland, 53659
        • NZOZ Wroclawskie Centrum Alzheimerowskie
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3040-278
        • Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Angelo
      • Torres Vedras, Portugal, 2560-280
        • CNS-Campus Neurologico Senior
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08028
        • Fundació ACE
      • Lleida, Spain, 25198
        • Hospital Universitari de Santa Maria
      • Madrid, Spain, 28006
        • Complejo Hospitalario Ruber Juan Bravo
      • Sevilla, Spain, 41009
        • Hospital Victoria Eugenia
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Córdoba
      • Cordoba, Córdoba, Spain, 14011
        • Hospital Universitario Reina Sofía
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20009
        • Policlinica Gipuzkoa
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
    • Vizcaya
      • Getxo, Vizcaya, Spain, 48993
        • Cae Oroitu
  • Sweden
      • Malmö, Sweden, 205 02
        • Skånes universitetssjukhus
      • Mölndal, Sweden, 205 02
        • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
      • Stockholm, Sweden, 141 86
        • Karolinska Universitetssjukhuset, Huddinge
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset
  • Switzerland
      • Biel/Bienne, Switzerland, 2501
        • Spitalzentrum Biel
      • Genève, Switzerland, 1205
        • Hôpitaux Universitaires de Geneve- HUG
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois
      • Lugano, Switzerland, 6900
        • Ospedale Regionale di Lugano
      • Schlieren, Switzerland, 8952
        • Institut fur Regenerative Medizin-IREM Universitat Zurich, Campus Schlieren
  • Taiwan
      • Changhua, Taiwan, 50004
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, Greater London, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology and Neurosurgery Centre
      • London, Greater London, United Kingdom, W1G 9JF
        • Re:Cognition Health Ltd (London)
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
    • Lothian Region
      • Edinburgh, Lothian Region, United Kingdom, EH10 5HF
        • The University of Edinburgh
    • Somerset
      • Bath, Somerset, United Kingdom, BA1 3NG
        • The RICE Centre
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G21 3UW
        • Queen Elizabeth University Hospital Campus
      • Motherwell, Strathclyde, United Kingdom, ML1 4UF
        • Glasgow Memory Clinic Ltd
    • Tayside Region
      • Dundee, Tayside Region, United Kingdom, DD1 9SY
        • Ninewells Hospital
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE4 5PL
        • Newcastle University
  • 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
        • Dignity Health
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
      • Tucson, Arizona, United States, 85718
        • Center for Neurosciences
    • California
      • Fullerton, California, United States, 92835
        • Neurology Center of North Orange County
      • Irvine, California, United States, 92607
        • UCI MIND
      • La Jolla, California, United States, 92037
        • University of California San Diego Medical Center
      • Laguna Hills, California, United States, 92653
        • Senior Clinical Trials, Inc.
      • Los Angeles, California, United States, 90033
        • USC Keck School of Medicine
      • Los Angeles, California, United States, 90095
        • Mary S. Easton Center for Alzheimer's Disease Research, UCLA
      • Oxnard, California, United States, 93030
        • Pacific Neuroscience Medical Group
      • Palo Alto, California, United States, 94304
        • Stanford Hospital and Clinics
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc
      • San Francisco, California, United States, 94143
        • UCSF - Memory and Aging Center
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
      • Centennial, Colorado, United States, 80112
        • IMMUNOe International Research Centers
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Yale University
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
      • New Haven, Connecticut, United States, 06510
        • Invicro
      • Norwalk, Connecticut, United States, 06851
        • Research Center for Clinical Studies, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Clinical Research Unit (CRU)
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center, Inc
      • Delray Beach, Florida, United States, 334405
        • Brain Matters Research
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Hollywood, Florida, United States, 33024
        • Infinity Clinical Research, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 33462
        • Mayo Clinic in Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33180
        • Miami Jewish Health System, Inc
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32806
        • Accelerated Enrollment Solutions (AES)
      • Orlando, Florida, United States, 32162
        • Accelerated Enrollment Solutions (AES)
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Neurological Center
      • Pompano Beach, Florida, United States, 33064
        • Quantum Laboratories Inc.
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials, LLC
      • Tampa, Florida, United States, 33634
        • Meridien Research
      • Tampa, Florida, United States, 33616
        • USF Health Byrd Institute
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida - Weston
    • 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
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Center - Neuroscience Research Institute
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Neurological Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
      • Indianapolis, Indiana, United States, 46256
        • Josephson, Wallack, Munshower Neurology, P.C.
    • 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, 40503
        • Baptist Health Lexington
    • Massachusetts
      • Belmont, Massachusetts, United States, 02474
        • McLean Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital Department of Neurology
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research, Inc.
      • Newton, Massachusetts, United States, 02459
        • Boston Center for Memory
      • Plymouth, Massachusetts, United States, 02360
        • Donald S. Marks, M.D., P.C.
    • Michigan
      • Rochester, Michigan, United States, 55902
        • Mayo Clinic
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic, PA
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University
    • 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 Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices & Research, Inc.
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Research Inst. of NJ, PC
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • 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, 10016
        • New York University Medical Center PRIME
      • New York, New York, United States, 10021
        • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
      • Rochester, New York, United States, 14620
        • University of Rochester
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
        • AMC Research, LLC
      • Raleigh, North Carolina, United States, 27607-6010
        • Raleigh Neurology Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Gastroenterology Associates of the Piedmont
      • Winston-Salem, North Carolina, United States, 27157-1207
        • Wake Forest Baptist Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center for Clinical Research, LLC
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Memory Center
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh
      • Wilkes-Barre, Pennsylvania, United States, 18705
        • Northeastern Pennsylvania Memory and Alzheimer's Center
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Rhode Island Mood & Memory Research Institute
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper St. Francis Healthcare
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic, PC
    • Texas
      • Austin, Texas, United States, 33410
        • Senior Adult Specialty Research
      • Dallas, Texas, United States, 75390-9129
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Health Sciences Center
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research Inc.-Richmond
    • Washington
      • Seattle, Washington, United States, 98104-2499
        • University of Washington Medical Centre
      • Spokane, Washington, United States, 99202
        • Kingfisher Cooperative, LLC
    • Wisconsin
      • 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

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

Core Treatment Period:

  • Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies).
  • Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.

LTE Treatment Period:

  • Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the Investigator.
  • Has one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.

Key Exclusion Criteria:

Core Treatment Period:

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment.
  • Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
  • 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.
  • A seizure event that occurred after the last visit of the feeder study and before Screening for this study.
  • Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.
  • History of or known seropositivity for HIV.
  • Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.
  • Contraindications to having a brain magnetic resonance imaging (MRI).

LTE Treatment Period:

  • Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aducanumab
Participants will be administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for a duration of 100 weeks during the Core Treatment Period. Eligible participants will continue to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the Long-Term Extension (LTE) Treatment Period.
Drug: Aducanumab
Administered as specified in the treatment arm.
Other Names:
  • BIIB037

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time Frame: From the first dose of study drug to end of follow-up (up to Week 118)
An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal(investigational) product, whether or not related to medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in significant disability/incapacity or congenital anomaly, is medically important event. TEAE or Serious TEAEs are defined as any AE that has an onset date and time that is on or after date and time of first dose of study treatment, or that has worsened after date and time of first dose of study treatment.
From the first dose of study drug to end of follow-up (up to Week 118)
Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW)
Time Frame: From the first dose of study drug to end of follow-up (up to Week 118)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From the first dose of study drug to end of follow-up (up to Week 118)
Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E)
Time Frame: Up to Week 118
Number of participants diagnosed with ARIA edema are reported.
Up to Week 118
Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)
Time Frame: Up to Week 118
Number of participants diagnosed with ARIA hemmorrhage or superficial siderosis are reported.
Up to Week 118
Core Treatment Period: Number of Participants With Positive Antidrug Antibodies (ADAs) in Serum
Time Frame: Up to Week 102
The presence of serum ADAs was determined using a validated assay. A standard 3-tiered approach was used including screening assay, confirmatory assay, and titration assay. The number of participants with a positive response to ADAs are reported.
Up to Week 102

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)

March 2, 2020

Primary Completion (Actual)

July 22, 2024

Study Completion (Actual)

July 22, 2024

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221AD304
  • 2019-004368-22 (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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