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NCT04241068TerminatedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 21 Feb 2025

Brief summary (registry, in English)

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).

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1696 (actual)
First submitted
22 Jan 2020
Start date
2 Mar 2020
Primary completion date
22 Jul 2024
Lead sponsor
Biogen
NCT number
NCT04241068
EudraCT number
2019-004368-22

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
  • History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening.
  • Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.

Other illness

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment.
  • Clinically significant unstable psychiatric illness in past 6 months.
  • A seizure event that occurred after the last visit of the feeder study and before Screening for this study.
  • History of or known seropositivity for HIV.
  • 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.

Other

  • Core Treatment Period:
  • Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.
  • Contraindications to having a brain magnetic resonance imaging (MRI).
    • LTE Treatment Period:

Who the study is looking for

  • 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.

Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (293)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Lkh - Universitaetsklinikum GrazGrazAustriaUnknown status
Christian-Doppler-Klinik - Universitätsklinikum SalzburgSalzburgAustriaUnknown status
AKH - Medizinische Universitat WienViennaAustriaUnknown status
Box Hill HospitalBox HillAustraliaUnknown status
The Prince Charles HospitalChermsideAustraliaUnknown status
St Vincent's Hospital SydneyDarlinghurstAustraliaUnknown status
Central Coast Neurosciences Research (Erina)ErinaAustraliaUnknown status
Austin HealthHeidelberg WestAustraliaUnknown status
KaRa Institute of Neurological DiseasesMacquarie ParkAustraliaUnknown status
Australian Alzheimer's Research FoundationNedlandsAustraliaUnknown status
Royal Melbourne HospitalParkvilleAustraliaUnknown status
AZ KLINABrasschaatBelgiumUnknown status
AZ Sint JanBrugesBelgiumUnknown status
Universitair Ziekenhuis BrusselBrusselsBelgiumUnknown status
Universitair Ziekenhuis GentGhentBelgiumUnknown status
AZ GroeningeKortrijkBelgiumUnknown status
UZ LeuvenLeuvenBelgiumUnknown status
AZ DeltaRoeselareBelgiumUnknown status
University of Calgary / Heritage Medical Research ClinicCalgaryCanadaUnknown status
Clinique de la Mémoire de l'OutaouaisGatineauCanadaUnknown status
Institut et Clinique MoCAGreenfield ParkCanadaUnknown status
True North Clinical Research - Halifax Inc.HalifaxCanadaUnknown status
The Medical Arts Health Research GroupKamloopsCanadaUnknown status
True North Clinical ResearchKentvilleCanadaUnknown status
St. Joseph's HC- Parkwood InstituteLondonCanadaUnknown status
Montreal Neurological Institute Clinical Research UnitMontrealCanadaUnknown status
Bruyere Continuing CareOttawaCanadaUnknown status
The Medical Arts Health Research GroupPentictonCanadaUnknown status
Kawartha Centre - Redefining Healthy AgingPeterboroughCanadaUnknown status
CHU de Quebec - Hôpital de l' Enfant JésusQuébecCanadaUnknown status
Toronto Sunnybrook HospitalTorontoCanadaUnknown status
Toronto Western HospitalTorontoCanadaUnknown status
Toronto Memory Program (Neurology Research Inc.)TorontoCanadaUnknown status
UBC HospitalVancouverCanadaUnknown status
Medical Arts Health Research GroupWest VancouverCanadaUnknown status
Spitalzentrum BielBiel/BienneSwitzerlandUnknown status
Hôpitaux Universitaires de Genève (HUG)GenevaSwitzerlandUnknown status
Centre Hospitalier Universitaire VaudoisLausanneSwitzerlandUnknown status
Ospedale Regionale di LuganoLuganoSwitzerlandUnknown status
Institut fur Regenerative Medizin-IREM Universitat Zurich, Campus SchlierenSchlierenSwitzerlandUnknown status
Universitaetsklinikum Aachen, AoeRAachenGermanyUnknown status
Klinikum Altenburger Land GmbHAltenburgGermanyUnknown status
Klinikum Bayreuth GmbH- Hohe WarteBayreuthGermanyUnknown status
Charite Universitaetsmedizin Berlin - Campus Berlin BuchBerlinGermanyUnknown status
Emovis GmbHBerlinGermanyUnknown status
Neurologie im Tempelhofer HafenBerlinGermanyUnknown status
Neurozentrum BielefeldBielefeldGermanyUnknown status
Studienzentrum fur Neurologie und PsychiatrieBöblingenGermanyUnknown status
Universitaetsklinikum KoelnCologneGermanyUnknown status
Universitaetsklinikum Duesseldorf AoeRDüsseldorfGermanyUnknown status
Neuro Centrum Science GmbH, Geschaftführende Gesellschafterin Barbara Unsorg und Prüfarzt Dr. med. GErbach im OdenwaldGermanyUnknown status
Bezirkskrankenhaus GuenzburgGünzburgGermanyUnknown status
Klinische Forschung Hannover-Mitte GmbHHanoverGermanyUnknown status
Neurologische Gemeinschaftspraxis KasselKasselGermanyUnknown status
ISPG - Institut fuer Studien zur Psychischen GesundheitMannheimGermanyUnknown status
Institut fuer Schlaganfall- und Demenzforschung (ISD)MünchenGermanyUnknown status
Klinikum rechts der Isar der TU MuenchenMunichGermanyUnknown status
Zentrum f. Neurologisch- Psychiatrische Studien und BegutachtungSiegenGermanyUnknown status
mind mvz GmbHStuttgartGermanyUnknown status
Universitaetsklinikum UlmUlmGermanyUnknown status
Neuropoint StudienzentrumUlmGermanyUnknown status
Neuropraxis Muenchen SuedUnterhachingGermanyUnknown status
CCBR - Ålborg - DKAalborgDenmarkUnknown status
Danish Dementia Research CentreCopenhagenDenmarkUnknown status
CCBR - Vejle - DKVejleDenmarkUnknown status
Fundació ACEBarcelonaSpainUnknown status
Hospital Clinic de BarcelonaBarcelonaSpainUnknown status
Hospital del MarBarcelonaSpainUnknown status
Hospital de la Santa Creu i Sant PauBarcelonaSpainUnknown status
Hospital Universitario Reina SofiaCórdobaSpainUnknown status
Policlínica GipuzkoaDonostia / San SebastianSpainUnknown status
Hospital General Universitario de ElcheElcheSpainUnknown status
Cae OroituGetxoSpainUnknown status
Hospital Universitari de Santa MariaLleidaSpainUnknown status
Complejo Hospitalario Ruber Juan BravoMadridSpainUnknown status
Clínica Universidad de navarraPamplonaSpainUnknown status
Hospital Victoria EugeniaSevilleSpainUnknown status
Hospital Universitario Dr. PesetValenciaSpainUnknown status
Hospital Universitari i Politécnic La FeValenciaSpainUnknown status
Terveystalo RuoholahtiHelsinkiFinlandUnknown status
Itä-Suomen yliopisto, AivotutkimusyksikköKuopioFinlandUnknown status
CRST, Clinical Research Services TurkuTurkuFinlandUnknown status
Groupe Hospitalier Pellegrin - Hôpital PellegrinBordeauxFranceUnknown status
CHU de Lyon - Hopital Neurologique Pierre WertheimerBronFranceUnknown status
CHU Lille - Hôpital Roger SalengroLilleFranceUnknown status
Hopital de la TimoneMarseilleFranceUnknown status
Hôpital Gui de ChauliacMontpellierFranceUnknown status
CHU Nantes - Hopital Nord LaënnecNantesFranceUnknown status
Groupe Hospitalier Pitie - SalpetriereParisFranceUnknown status
Hôpital BrocaParisFranceUnknown status
Hôpital LariboisièreParisFranceUnknown status
CHU Reims Hôpital Maison BlancheReimsFranceUnknown status
Chu Rennes PontchaillouRennesFranceUnknown status
CHU Strasbourg - Hôpital HautepierreStrasbourgFranceUnknown status
Hopital PurpanToulouseFranceUnknown status
Hôpital La GraveToulouseFranceUnknown status
Hôpital des ChapennesVilleurbanneFranceUnknown status
The RICE CentreBathUnited KingdomUnknown status
Ninewells HospitalDundeeUnited KingdomUnknown status
The University of EdinburghEdinburghUnited KingdomUnknown status
Queen Elizabeth University Hospital CampusGlasgowUnited KingdomUnknown status
Charing Cross HospitalLondonUnited KingdomUnknown status
The National Hospital for Neurology and Neurosurgery CentreLondonUnited KingdomUnknown status
Re:Cognition Health Ltd (London)LondonUnited KingdomUnknown status
Manchester Royal InfirmaryManchesterUnited KingdomUnknown status
Glasgow Memory Clinic LtdMotherwellUnited KingdomUnknown status
Newcastle UniversityNewcastle upon TyneUnited KingdomUnknown status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali CiviliBresciaItalyUnknown status
Fondazione Istituto G.Giglio di CefalùCefalùItalyUnknown status
Azienda Ospedaliero Universitaria San MartinoGenovaItalyUnknown status
Fondazione IRCCS Istituto Neurologico Carlo BestaMilanItalyUnknown status
Ospedale San RaffaeleMilanItalyUnknown status
Asst Di MonzaMonzaItalyUnknown status
AOU dell'Università degli Studi della Campania Luigi VanvitelliNaplesItalyUnknown status
Azienda Ospedaliera e Universitaria di PerugiaPerugiaItalyUnknown status
Azienda Ospedaliero Universitaria PisanaPisaItalyUnknown status
Ospedale degli InfermiPonderanoItalyUnknown status
Fondazione Santa Lucia IRCCSRomaItalyUnknown status
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRomaItalyUnknown status
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La SapienzaRomaItalyUnknown status
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'AragonaSalernoItalyUnknown status
A.O.U. Senese Policlinico Santa Maria alle ScotteSienaItalyUnknown status
Azienda Ospedaliera Card. G. PanicoTricaseItalyUnknown status
-Aizu-WakamatsuJapanUnknown status
-Amagasaki-shiJapanUnknown status
-Asahikawa-shiJapanUnknown status
-Bunkyō CityJapanUnknown status
-ChibaJapanUnknown status
-FukuokaJapanUnknown status
-Himeji-shiJapanUnknown status
-Inzai-shiJapanUnknown status
-Iruma-GunJapanUnknown status
-Kamakura-shiJapanUnknown status
-Kasukabe-shiJapanUnknown status
-Kita-gunJapanUnknown status
-Kiyose-shiJapanUnknown status
-KobeJapanUnknown status
-Kodaira-shiJapanUnknown status
-Kurashiki-shiJapanUnknown status
-Kurume-shiJapanUnknown status
-KyotoJapanUnknown status
-Nagaoka-shiJapanUnknown status
-Obu-shiJapanUnknown status
-OkayamaJapanUnknown status
-OsakaJapanUnknown status
-Otake-shiJapanUnknown status
-SapporoJapanUnknown status
-Shizuka-shiJapanUnknown status
-ShizuokaJapanUnknown status
-Suita-shiJapanUnknown status
-TogitsuJapanUnknown status
-Toon-ShiJapanUnknown status
-TsuJapanUnknown status
-TsukubaJapanUnknown status
-YamagataJapanUnknown status
-Yufu-shiJapanUnknown status
Gachon University Gil Medical CenterIncheonSouth KoreaUnknown status
Inha University HospitalIncheonSouth KoreaUnknown status
Seoul National University Bundang HospitalSeongnam-siSouth KoreaUnknown status
Konkuk University Medical CenterSeoulSouth KoreaUnknown status
Asan Medical CenterSeoulSouth KoreaUnknown status
Samsung Medical CenterSeoulSouth KoreaUnknown status
Brain Research CenterAmsterdamNetherlandsUnknown status
Amphia Ziekenhuis MolengrachtBredaNetherlandsUnknown status
Erasmus Medisch CentrumRotterdamNetherlandsUnknown status
Podlaskie Centrum PsychogeriatriiBialystokPolandUnknown status
Pallmed Sp. z o.o.BydgoszczPolandUnknown status
Klinika Psychiatrii Doroslych UCKGdanskPolandUnknown status
Novo-Med Zielinski I Wspolnicy Sp. j.KatowicePolandUnknown status
SPZOZ Centralny Szpital Kliniczny UM w LodziLodzPolandUnknown status
Samodzielny Publiczny Szpital Kliniczny Nr 4 w LublinieLublinPolandUnknown status
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. LekPoznanPolandUnknown status
Neuro-Care Gabriela KlodowskaSiemianowice ŚląskiePolandUnknown status
Centrum Medyczne SENIORSopotPolandUnknown status
Osrodek Badan Klinicznych EuromedisSzczecinPolandUnknown status
Centrum Medyczne NeuroProtectWarsawPolandUnknown status
NZOZ Wroclawskie Centrum AlzheimerowskieWroclawPolandUnknown status
Hospital de BragaBragaPortugalUnknown status
Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospitais da Universidade de CoimbraCoimbraPortugalUnknown status
Hospital Beatriz ÂngeloLouresPortugalUnknown status
CNS - Campus Neurologico SeniorTorres VedrasPortugalUnknown status
Skånes universitetssjukhusMalmöSwedenUnknown status
Sahlgrenska Universitetssjukhuset, Mölndal SjukhusMölndalSwedenUnknown status
Karolinska universitetssjukhuset - HuddingeStockholmSwedenUnknown status
Akademiska sjukhusetUppsalaSwedenUnknown status
Changhua Christian Medical Foundation Changhua Christian HospitalChanghuaTaiwanUnknown status
Kaohsiung Chang Gung Memorial HospitalKaohsiung CityTaiwanUnknown status
National Cheng Kung University HospitalTainanTaiwanUnknown status
Taipei Veterans General HospitalTaipeiTaiwanUnknown status
Chang Gung Memorial Hospital LinkouTaoyuan CityTaiwanUnknown status
Albany Medical CollegeAlbanyUnited StatesUnknown status
Lehigh Center for Clinical Research LLCAllentownUnited StatesUnknown status
Emory University Cognitive Neurology Clinic & ADRCAtlantaUnited StatesUnknown status
JEM ResearchAtlantisUnited StatesUnknown status
University of Colorado DenverAuroraUnited StatesUnknown status
Senior Adult Specialty ResearchAustinUnited StatesUnknown status
McLean HospitalBelmontUnited StatesUnknown status
The Memory ClinicBenningtonUnited StatesUnknown status
University of Alabama at BirminghamBirminghamUnited StatesUnknown status
Beth Israel Deaconess Medical CenterBostonUnited StatesUnknown status
Brigham and Women's Hospital Department of NeurologyBostonUnited StatesUnknown status
Bradenton Research Center, Inc.BradentonUnited StatesUnknown status
IMMUNOe International Research CentersCentennialUnited StatesUnknown status
Medical University of South Carolina (MUSC)CharlestonUnited StatesUnknown status
Roper St. Francis HealthcareCharlestonUnited StatesUnknown status
AMC Research, LLCCharlotteUnited StatesUnknown status
Cleveland Clinic FoundationClevelandUnited StatesUnknown status
Medical Research Health and Education Foundation, IncColumbusUnited StatesUnknown status
Ohio State University Wexner Medical CenterColumbusUnited StatesUnknown status
Neurology Clinic, PCCordovaUnited StatesUnknown status
UT Southwestern Medical CenterDallasUnited StatesUnknown status
NeuroStudies.net, LLCDecaturUnited StatesUnknown status
Brain Matters ResearchDelray BeachUnited StatesUnknown status
Rhode Island Mood & Memory Research InstituteEast ProvidenceUnited StatesUnknown status
Alexian Brothers Medical Center - Neuroscience Research InstituteElk Grove VillageUnited StatesUnknown status
Yale UniversityFairfieldUnited StatesUnknown status
University of Kansas Medical Center Research Institute, Inc.FairwayUnited StatesUnknown status
Neuropsychiatric Research Center of Southwest FloridaFort MyersUnited StatesUnknown status
Fort Wayne Neurological CenterFort WayneUnited StatesUnknown status
Neurology Center of North Orange CountyFullertonUnited StatesUnknown status
Hattiesburg Clinic, PAHattiesburgUnited StatesUnknown status
Infinity Clinical Research, LLCHollywoodUnited StatesUnknown status
Clinical Trial NetworkHoustonUnited StatesUnknown status
Baylor College of MedicineHoustonUnited StatesUnknown status
Indiana University School of MedicineIndianapolisUnited StatesUnknown status
Josephson Wallack Munshower Neurology P.C.IndianapolisUnited StatesUnknown status
UCI MINDIrvineUnited StatesUnknown status
Mayo Clinic in FloridaJacksonvilleUnited StatesUnknown status
Jacksonville Center for Clinical ResearchJacksonvilleUnited StatesUnknown status
The Clinical Trial Center, LLCJenkintownUnited StatesUnknown status
Senior Clinical Trials, Inc.Laguna HillsUnited StatesUnknown status
University of California San Diego Medical CenterLa JollaUnited StatesUnknown status
Cleveland Clinic Lou Ruvo Center for Brain HealthLas VegasUnited StatesUnknown status
Las Vegas Medical ResearchLas VegasUnited StatesUnknown status
Empire Neurology, PCLathamUnited StatesUnknown status
Baptist Health LexingtonLexingtonUnited StatesUnknown status
Mary S. Easton Center for Alzheimer's Disease Research, UCLALos AngelesUnited StatesUnknown status
USC Keck School of MedicineLos AngelesUnited StatesUnknown status
ActivMed Practices & Research, IncMethuenUnited StatesUnknown status
University of MiamiMiamiUnited StatesUnknown status
Miami Jewish Health System, IncMiamiUnited StatesUnknown status
Medical College of Wisconsin, IncMilwaukeeUnited StatesUnknown status
InvicroNew HavenUnited StatesUnknown status
Yale University School Of MedicineNew HavenUnited StatesUnknown status
Boston Center for MemoryNewtonUnited StatesUnknown status
Mount Sinai School of MedicineNew YorkUnited StatesUnknown status
New York University Medical Center PRIMENew YorkUnited StatesUnknown status
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)New YorkUnited StatesUnknown status
Research Center for Clinical Studies, Inc.NorwalkUnited StatesUnknown status
Renstar Medical ResearchOcalaUnited StatesUnknown status
Lynn Health Science InstituteOklahoma CityUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.OrlandoUnited StatesUnknown status
Accelerated Enrollment Solutions (AES)OrlandoUnited StatesUnknown status
Pacific Neuroscience Medical GroupOxnardUnited StatesUnknown status
Palm Beach Neurological CenterPalm Beach GardensUnited StatesUnknown status
Stanford Hospital and ClinicsPalo AltoUnited StatesUnknown status
Advocate Lutheran General HospitalPark RidgeUnited StatesUnknown status
Penn Memory CenterPhiladelphiaUnited StatesUnknown status
Dignity HealthPhoenixUnited StatesUnknown status
Banner Alzheimer's InstitutePhoenixUnited StatesUnknown status
University of PittsburghPittsburghUnited StatesUnknown status
Donald S.Marks, M.D.,P.C.PlymouthUnited StatesUnknown status
Quantum Laboratories IncPompano BeachUnited StatesUnknown status
ActivMed Practices & Research, Inc.PortsmouthUnited StatesUnknown status
Butler HospitalProvidenceUnited StatesUnknown status
Rhode Island HospitalProvidenceUnited StatesUnknown status
Raleigh Neurology AssociatesRaleighUnited StatesUnknown status
Anderson Clinical ResearchRedlandsUnited StatesUnknown status
National Clinical Research Inc.-RichmondRichmondUnited StatesUnknown status
University of RochesterRochesterUnited StatesUnknown status
Mayo ClinicRochesterUnited StatesUnknown status
University of Utah Health Sciences CenterSalt Lake CityUnited StatesUnknown status
Pacific Research Network, IncSan DiegoUnited StatesUnknown status
UCSF Memory and Aging CenterSan FranciscoUnited StatesUnknown status
Syrentis Clinical ResearchSanta AnaUnited StatesUnknown status
University of Washington Medical CentreSeattleUnited StatesUnknown status
California Neuroscience Research Medical Group, Inc.Sherman OaksUnited StatesUnknown status
Kingfisher Cooperative LLCSpokaneUnited StatesUnknown status
Washington UniversitySt LouisUnited StatesUnknown status
Banner Sun Health Research InstituteSun CityUnited StatesUnknown status
Axiom Clinical Research of FloridaTampaUnited StatesUnknown status
Stedman Clinical Trials, LLCTampaUnited StatesUnknown status
USF Health Byrd InstituteTampaUnited StatesUnknown status
Meridien ResearchTampaUnited StatesUnknown status
Advanced Memory Research Inst. of NJ, PCToms RiverUnited StatesUnknown status
Center for NeurosciencesTucsonUnited StatesUnknown status
Georgetown University Clinical Research Unit (CRU)Washington D.C.United StatesUnknown status
Cleveland Clinic Florida- WestonWestonUnited StatesUnknown status
Premiere Research InstituteWest Palm BeachUnited StatesUnknown status
Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.WichitaUnited StatesUnknown status
Northeastern Pennsylvania Memory and Alzheimer's CenterWilkes-BarreUnited StatesUnknown status
Gastroenterology Associates of the PiedmontWinston-SalemUnited StatesUnknown status
Wake Forest Baptist HealthWinston-SalemUnited StatesUnknown status

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