AzTrials
AzTrials

Alzheimer's DiseasePhase 3NCT04241068

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

A Phase 3 study testing Aducanumab in people with Alzheimer's Disease, run by Biogen at 297 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Aducanumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,696 participants
Where
297 sitesin 20 countries
Study dates
2 Mar 2020to 22 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

297 sites in 20 countries.

297 sites in 20 countries

United States104 sites

  • Albany Medical College

    Albany, New York, 12208

  • Lehigh Center for Clinical Research, LLC

    Allentown, Pennsylvania, 18104

  • Emory University Cognitive Neurology Clinic & ADRC

    Atlanta, Georgia, 30329

  • JEM Research

    Atlantis, Florida, 33462

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Senior Adult Specialty Research

    Austin, Texas, 33410

  • McLean Hospital

    Belmont, Massachusetts, 02474

  • The Memory Clinic

    Bennington, Vermont, 05201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Brigham and Women's Hospital Department of Neurology

    Boston, Massachusetts, 02215

  • Bradenton Research Center, Inc

    Bradenton, Florida, 34205

  • IMMUNOe International Research Centers

    Centennial, Colorado, 80112

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29401

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • AMC Research, LLC

    Charlotte, North Carolina, 28270

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Research Health and Education Foundation, Inc

    Columbus, Georgia, 31909

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9129

  • NeuroStudies.net, LLC

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 334405

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Alexian Brothers Medical Center - Neuroscience Research Institute

    Elk Grove Village, Illinois, 60007

  • Yale University

    Fairfield, Connecticut, 06824

  • University of Kansas Medical Center Research Institute, Inc.

    Fairway, Kansas, 66205

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Hattiesburg Clinic, PA

    Hattiesburg, Mississippi, 39401

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33024

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Clinical Trial Network

    Houston, Texas, 77074

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Josephson, Wallack, Munshower Neurology, P.C.

    Indianapolis, Indiana, 46256

  • UCI MIND

    Irvine, California, 92607

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 33462

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • University of California San Diego Medical Center

    La Jolla, California, 92037

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Empire Neurology, PC

    Latham, New York, 12110

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • USC Keck School of Medicine

    Los Angeles, California, 90033

  • Mary S. Easton Center for Alzheimer's Disease Research, UCLA

    Los Angeles, California, 90095

  • ActivMed Practices & Research, Inc.

    Methuen, Massachusetts, 01844

  • University of Miami

    Miami, Florida, 33136

  • Miami Jewish Health System, Inc

    Miami, Florida, 33180

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

  • Invicro

    New Haven, Connecticut, 06510

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • New York University Medical Center PRIME

    New York, New York, 10016

  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Accelerated Enrollment Solutions (AES)

    Orlando, Florida, 32162

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Accelerated Enrollment Solutions (AES)

    Orlando, Florida, 32806

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33410

  • Stanford Hospital and Clinics

    Palo Alto, California, 94304

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Penn Memory Center

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Dignity Health

    Phoenix, Arizona, 85013

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

  • Donald S. Marks, M.D., P.C.

    Plymouth, Massachusetts, 02360

  • Quantum Laboratories Inc.

    Pompano Beach, Florida, 33064

  • ActivMed Practices & Research, Inc.

    Portsmouth, New Hampshire, 03801

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6010

  • Anderson Clinical Research

    Redlands, California, 92374

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia, 23294

  • Mayo Clinic

    Rochester, Michigan, 55902

  • University of Rochester

    Rochester, New York, 14620

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84108

  • Pacific Research Network, Inc

    San Diego, California, 92103

  • UCSF - Memory and Aging Center

    San Francisco, California, 94143

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • University of Washington Medical Centre

    Seattle, Washington, 98104-2499

  • California Neuroscience Research Medical Group Inc.

    Sherman Oaks, California, 91403

  • Kingfisher Cooperative, LLC

    Spokane, Washington, 99202

  • Washington University

    St Louis, Missouri, 63108

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • USF Health Byrd Institute

    Tampa, Florida, 33616

  • Meridien Research

    Tampa, Florida, 33634

  • Advanced Memory Research Inst. of NJ, PC

    Toms River, New Jersey, 08755

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Georgetown University Clinical Research Unit (CRU)

    Washington D.C., District of Columbia, 20007

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Cleveland Clinic Florida - Weston

    Weston, Florida, 33331

  • Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.

    Wichita, Kansas, 67214

  • Northeastern Pennsylvania Memory and Alzheimer's Center

    Wilkes-Barre, Pennsylvania, 18705

  • Gastroenterology Associates of the Piedmont

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157-1207

Other trials in United States

Japan36 sites

  • Research Site

    Aizu-Wakamatsu, Fukushima, 965-8585

  • Research Site

    Amagasaki-shi, Hyōgo, 660-8511

  • Research Site

    Asahikawa-shi, Hokkaido, 070-8644

  • Research Site

    Bunkyō City, Tokyo-To, 113-0034

  • Research Site

    Chiba, Chiba, 260-8656

  • Research Site

    Chiba, Chiba, 263-0043

  • Research Site

    Fukuoka, Fukuoka, 814-0180

  • Research Site

    Himeji-shi, Hyōgo, 670-0981

  • Research Site

    Himeji-shi, Hyōgo, 672-8043

  • Research Site

    Inzai-shi, Chiba, 270-1694

  • Research Site

    Iruma-gun, Saitama, 350-0495

  • Research Site

    Kamakura-shi, Kanagawa, 247-8533

  • Research Site

    Kasukabe-shi, Saitama, 344-0036

  • Research Site

    Kita-gun, Kagawa-ken, 761-0793

  • Research Site

    Kiyose-shi, Tokyo-To, 204-8585

  • Research Site

    Kobe, Hyōgo, 650-0047

  • Research Site

    Kodaira-shi, Tokyo-To, 187-8551

  • Research Site

    Kurashiki-shi, Okayama-ken, 247-8533

  • Research Site

    Kurume-shi, Fukuoka, 830-0011

  • Research Site

    Kyoto, Kyoto, 607-8113

  • Research Site

    Kyoto, Kyoto, 616-8255

  • Research Site

    Nagaoka-shi, Niigata, 940-2081

  • Research Site

    Obu-shi, Aichi-ken, 474-8511

  • Research Site

    Okayama, Okayama-ken, 703-8265

  • Research Site

    Osaka, Osaka, 545-8586

  • Research Site

    Otake-shi, Hiroshima, 739-0696

  • Research Site

    Sapporo, Hokkaido, 064-8570

  • Research Site

    Shizuka-shi, Shizuoka, 424-8636

  • Research Site

    Shizuoka, Shizuoka, 420-8688

  • Research Site

    Suita-shi, Osaka, 565-0871

  • Research Site

    Togitsu, Nagasaki, 851-2103

  • Research Site

    Toon-shi, Ehime, 791-0295

  • Research Site

    Tsu, Mie-ken, 514-8507

  • Research Site

    Tsukuba, Okayama-ken, 701-0304

  • Research Site

    Yamagata, Yamagata, 990-0834

  • Research Site

    Yufu-shi, Oita Prefecture, 879-5593

Other trials in Japan

Germany22 sites

  • Universitaetsklinikum Aachen AOeR

    Aachen, North Rhine-Westphalia, 52074

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 04600

  • Klinikum Bayreuth GmbH- Hohe Warte

    Bayreuth, Bavaria, 95445

  • Emovis GmbH

    Berlin, 10629

  • Neurologie im Tempelhofer Hafen

    Berlin, 12099

  • Charite Universitaetsmedizin Berlin - Campus Berlin Buch

    Berlin, 13125

  • Neurozentrum Bielefeld

    Bielefeld, North Rhine-Westphalia, 33647

  • Studienzentrum fur Neurologie und Psychiatrie

    Böblingen, Baden-Wurttemberg, 71034

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40225

  • Neuro Centrum Science GmbH, Geschaftführende Gesellschafterin Barbara Unsorg und Prüfarzt Dr. med. G

    Erbach im Odenwald, Hesse, 64711

  • Bezirkskrankenhaus Guenzburg

    Günzburg, Bavaria, 89312

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, Lower Saxony, 30159

  • Neurologische Gemeinschaftspraxis Kassel

    Kassel, Hesse, 34121

  • ISPG - Institut fuer Studien zur Psychischen Gesundheit

    Mannheim, Baden-Wurttemberg, 68165

  • Institut fuer Schlaganfall- und Demenzforschung (ISD)

    München, Bavaria, 81377

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675

  • Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

    Siegen, North Rhine-Westphalia, 57076

  • mind mvz GmbH

    Stuttgart, Baden-Wurttemberg, 70182

  • Neuropoint Studienzentrum

    Ulm, Baden-Wurttemberg, 89073

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Neuropraxis Muenchen Sued

    Unterhaching, Bavaria, 82008

Other trials in Germany

Canada17 sites

  • University of Calgary - Heritage Medical Research Clinic

    Calgary, Alberta, T2N4Z6

  • Clinique de la Memoire de l'Outaouais

    Gatineau, Quebec, J8T 8J1

  • Institut et Clinique MoCA

    Greenfield Park, Quebec, J4V 2J2

  • True North Clinical Research - Halifax Inc.

    Halifax, Nova Scotia, B3S 1M7

  • The Medical Arts Health Research Group

    Kamloops, British Columbia, V2C 5T1

  • True North Clinical Research

    Kentville, Nova Scotia, MB3 2S7

  • St. Joseph's HC- Parkwood Institute

    London, Ontario, N6C OA7

  • Montreal Neurological Institute Clinical Research Unit

    Montreal, Quebec, H3A 2B4

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • The Medical Arts Health Research Group

    Penticton, British Columbia, V2A 5L5

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H 2P4

  • CHU de Quebec - Hôpital de l' Enfant Jésus

    Québec, G1J 1Z4

  • Toronto Memory Program (Neurology Research Inc.)

    Toronto, Ontario, M3B 2S7

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • UBC Hospital

    Vancouver, British Columbia, V6T 1Z3

  • Medical Arts Health Research Group

    West Vancouver, British Columbia, V7T 1C5

Other trials in Canada

Italy16 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

  • Fondazione Istituto G.Giglio di Cefalù

    Cefalù, Palermo, 90015

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

  • ASST di Monza

    Monza, Milano, 20052

  • AOU dell'Università degli studi della Campania Luigi Vanvitelli

    Naples, 80138

  • Azienda Ospedaliera e Universitaria di Perugia

    Perugia, 06156

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Ospedale degli Infermi

    Ponderano, Biella, 13875

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Fondazione Santa Lucia IRCCS

    Roma, 179

  • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

    Salerno, 84131

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

  • Azienda Ospedaliera Card. G. Panico

    Tricase, Lecce, 73039

Other trials in Italy

France15 sites

  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin

    Bordeaux, Gironde, 33076

  • CHU de Lyon - Hopital Neurologique Pierre Wertheimer

    Bron, Rhone, 69677

  • CHU Lille - Hopital Roger Salengro

    Lille, Nord, 59037

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295

  • CHU Nantes - Hopital Nord Laënnec

    Nantes, Loire Atlantique, 44093

  • Hôpital Lariboisière

    Paris, Paris, 75010

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • Hôpital Broca

    Paris, 75013

  • CHU Reims - Hôpital Maison Blanche

    Reims, Marne, 51092

  • CHU Rennes - Pontchaillou

    Rennes, Ille Et Vilaine, 35033

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Bas Rhin, 67098

  • Hopital Purpan

    Toulouse, Haute Garonne, 31059

  • Hôpital La Grave

    Toulouse, Haute Garonne, 31059

  • Hôpital des Chapennes

    Villeurbanne, Rhone, 69100

Other trials in France

Spain14 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Fundacio ACE

    Barcelona, 08028

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14011

  • Policlinica Gipuzkoa

    Donostia / San Sebastian, Guipuzcoa, 20009

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • CAE Oroitu

    Getxo, Vizcaya, 48993

  • Hospital Universitari de Santa Maria

    Lleida, 25198

  • Complejo Hospitalario Ruber Juan Bravo

    Madrid, 28006

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Victoria Eugenia

    Seville, 41009

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Poland12 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • PALLMED Sp. z o.o.

    Bydgoszcz, 85-023

  • Klinika Psychiatrii Doroslych UCK

    Gdansk, 80-952

  • Novo-Med Zielinski i wspolnicy Sp. j.

    Katowice, 40-650

  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi

    Lodz, 92-216

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

  • NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.

    Poznan, 61-853

  • Neuro-Care Gabriela Klodowska

    Siemianowice Śląskie, 41-100

  • Centrum Medyczne Senior

    Sopot, 81-855

  • Osrodek Badan Klinicznych EUROMEDIS

    Szczecin, 70-111

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684

  • NZOZ Wroclawskie Centrum Alzheimerowskie

    Wroclaw, 53659

Other trials in Poland

United Kingdom10 sites

  • The RICE Centre

    Bath, Somerset, BA1 3NG

  • Ninewells Hospital

    Dundee, Tayside Region, DD1 9SY

  • The University of Edinburgh

    Edinburgh, Lothian Region, EH10 5HF

  • Queen Elizabeth University Hospital Campus

    Glasgow, Strathclyde, G21 3UW

  • Re:Cognition Health Ltd (London)

    London, Greater London, W1G 9JF

  • Charing Cross Hospital

    London, Greater London, W6 8RF

  • The National Hospital for Neurology and Neurosurgery Centre

    London, Greater London, WC1N 3BG

  • Manchester Royal Infirmary

    Manchester, Greater Manchester, M13 9WL

  • Glasgow Memory Clinic Ltd

    Motherwell, Strathclyde, ML1 4UF

  • Newcastle University

    Newcastle upon Tyne, Tyne & Wear, NE4 5PL

Other trials in United Kingdom

Australia8 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • The Prince Charles Hospital

    Chermside, New South Wales, 4032

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Central Coast Neurosciences Research (Erina)

    Erina, New South Wales, 2250

  • Austin Health

    Heidelberg West, Victoria, 3081

  • KaRa Institute of Neurological Diseases

    Macquarie Park, New South Wales, 2113

  • Australian Alzheimer's Research Foundation

    Nedlands, Western Australia, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Belgium7 sites

  • AZ Klina

    Brasschaat, 2930

  • AZ Sint-Jan

    Bruges, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

South Korea6 sites

  • Inha University Hospital

    Incheon, Gyeonggi-do, 22332

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

Switzerland5 sites

  • Spitalzentrum Biel

    Biel/Bienne, 2501

  • Hôpitaux Universitaires de Geneve- HUG

    Geneva, 1205

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • Ospedale Regionale di Lugano

    Lugano, 6900

  • Institut fur Regenerative Medizin-IREM Universitat Zurich, Campus Schlieren

    Schlieren, 8952

Other trials in Switzerland

Taiwan5 sites

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua, 50004

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 333

Other trials in Taiwan

Portugal4 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra

    Coimbra, 3040-278

  • Hospital Beatriz Ângelo

    Loures, 2674-514

  • CNS-Campus Neurologico Senior

    Torres Vedras, 2560-280

Other trials in Portugal

Sweden4 sites

  • Skånes Universitetssjukhus

    Malmö, 205 02

  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

    Mölndal, 205 02

  • Karolinska Universitetssjukhuset, Huddinge

    Stockholm, 141 86

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Austria3 sites

  • LKH - Universitaetsklinikum Graz

    Graz, 8036

  • Christian-Doppler-Klinik - Universitätsklinikum Salzburg

    Salzburg, 5020

  • AKH - Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Denmark3 sites

  • CCBR - Ålborg - DK

    Aalborg, 9000

  • Danish Dementia Research Centre

    Copenhagen, 2100

  • CCBR - Vejle - DK

    Vejle, 7100

Other trials in Denmark

Finland3 sites

  • Terveystalo Ruoholahti

    Helsinki, 00180

  • Itä-Suomen yliopisto, Aivotutkimusyksikkö

    Kuopio, 70210

  • CRST, Clinical Research Services Turku

    Turku, 20520

Other trials in Finland

Netherlands3 sites

  • Brain Research Center

    Amsterdam, 1081 GN

  • Amphia Ziekenhuis, Molengracht

    Breda, 4818 CK

  • Erasmus Medisch Centrum

    Rotterdam, 3015 AA

Other trials in Netherlands

About this study

Official title: 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).

Being tested
Aducanumab
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AducanumabDrug

    Also called BIIB037

    Administered as specified in the treatment arm.

Study groups in NCT04241068
Study groupRoleWhat they receive
AducanumabExperimentalParticipants 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.
Receives: Drug: Aducanumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

    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.

    Measured: From the first dose of study drug to end of follow-up (up to Week 118)

  2. Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW)

    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.

    Measured: From the first dose of study drug to end of follow-up (up to Week 118)

  3. Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E)

    Number of participants diagnosed with ARIA edema are reported.

    Measured: Up to Week 118

  4. Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)

    Number of participants diagnosed with ARIA hemmorrhage or superficial siderosis are reported.

    Measured: Up to Week 118

  5. Core Treatment Period: Number of Participants With Positive Antidrug Antibodies (ADAs) in Serum

    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.

    Measured: Up to Week 102

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start2 Mar 2020
  3. Primary completion22 Jul 2024
  4. Study completion22 Jul 2024

Why it stopped: Sponsor's Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,696 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04241068
Sponsor's protocol ID
221AD304
Other IDs
2019-004368-22, 2019
Status last verified
Jan 2025
First submitted
22 Jan 2020
Last updated
21 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Publications

  • Pang M, Brothers HM, O'Gorman J, Murphy J, Zabar Y, Lasky T, Shen C, Rubino I, Knopman D. Longitudinal clinical outcomes after amyloid clearance in aducanumab phase 3 studies. Alzheimers Dement. 2026 Oct;22(10):e71758. doi: 10.1002/alz.71758.

    PubMed 42841310

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aducanumab in people with Alzheimer's Disease, run by Biogen at 297 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 297 sites in United States, Japan, Germany, Canada, Italy and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04241068, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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