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
NCT ID: NCT04241068
Last Updated: 2025-02-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
1696 participants
INTERVENTIONAL
2020-03-02
2024-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Aducanumab
Administered as specified in the treatment arm.
Interventions
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Aducanumab
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
50 Years
90 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Dignity Health
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
UCI MIND
Irvine, California, United States
University of California San Diego Medical Center
La Jolla, California, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
Mary S. Easton Center for Alzheimer's Disease Research, UCLA
Los Angeles, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Stanford Hospital and Clinics
Palo Alto, California, United States
Anderson Clinical Research
Redlands, California, United States
Pacific Research Network, Inc
San Diego, California, United States
UCSF - Memory and Aging Center
San Francisco, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
California Neuroscience Research Medical Group Inc.
Sherman Oaks, California, United States
University of Colorado Denver
Aurora, Colorado, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
Yale University
Fairfield, Connecticut, United States
Invicro
New Haven, Connecticut, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Georgetown University Clinical Research Unit (CRU)
Washington D.C., District of Columbia, United States
JEM Research
Atlantis, Florida, United States
Bradenton Research Center, Inc
Bradenton, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Miami Jewish Health System, Inc
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Accelerated Enrollment Solutions (AES)
Orlando, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Accelerated Enrollment Solutions (AES)
Orlando, Florida, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States
Quantum Laboratories Inc.
Pompano Beach, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
USF Health Byrd Institute
Tampa, Florida, United States
Meridien Research
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Cleveland Clinic Florida - Weston
Weston, Florida, United States
Emory University Cognitive Neurology Clinic & ADRC
Atlanta, Georgia, United States
Medical Research Health and Education Foundation, Inc
Columbus, Georgia, United States
NeuroStudies.net, LLC
Decatur, Georgia, United States
Alexian Brothers Medical Center - Neuroscience Research Institute
Elk Grove Village, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Josephson, Wallack, Munshower Neurology, P.C.
Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute, Inc.
Fairway, Kansas, United States
Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
McLean Hospital
Belmont, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital Department of Neurology
Boston, Massachusetts, United States
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts, United States
Mayo Clinic
Rochester, Michigan, United States
Hattiesburg Clinic, PA
Hattiesburg, Mississippi, United States
Washington University
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, United States
Advanced Memory Research Inst. of NJ, PC
Toms River, New Jersey, United States
Albany Medical College
Albany, New York, United States
Empire Neurology, PC
Latham, New York, United States
New York University Medical Center PRIME
New York, New York, United States
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Rochester
Rochester, New York, United States
AMC Research, LLC
Charlotte, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Gastroenterology Associates of the Piedmont
Winston-Salem, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research, LLC
Allentown, Pennsylvania, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Penn Memory Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Northeastern Pennsylvania Memory and Alzheimer's Center
Wilkes-Barre, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Roper St. Francis Healthcare
Charleston, South Carolina, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Neurology Clinic, PC
Cordova, Tennessee, United States
Senior Adult Specialty Research
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
The Memory Clinic
Bennington, Vermont, United States
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States
University of Washington Medical Centre
Seattle, Washington, United States
Kingfisher Cooperative, LLC
Spokane, Washington, United States
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
The Prince Charles Hospital
Chermside, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Central Coast Neurosciences Research (Erina)
Erina, New South Wales, Australia
KaRa Institute of Neurological Diseases
Macquarie Park, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg West, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, Australia
LKH - Universitaetsklinikum Graz
Graz, , Austria
Christian-Doppler-Klinik - Universitätsklinikum Salzburg
Salzburg, , Austria
AKH - Medizinische Universität Wien
Vienna, , Austria
AZ Klina
Brasschaat, , Belgium
AZ Sint-Jan
Bruges, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Delta
Roeselare, , Belgium
University of Calgary - Heritage Medical Research Clinic
Calgary, Alberta, Canada
The Medical Arts Health Research Group
Kamloops, British Columbia, Canada
The Medical Arts Health Research Group
Penticton, British Columbia, Canada
UBC Hospital
Vancouver, British Columbia, Canada
Medical Arts Health Research Group
West Vancouver, British Columbia, Canada
True North Clinical Research - Halifax Inc.
Halifax, Nova Scotia, Canada
True North Clinical Research
Kentville, Nova Scotia, Canada
St. Joseph's HC- Parkwood Institute
London, Ontario, Canada
Bruyere Continuing Care
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, Canada
Institut et Clinique MoCA
Greenfield Park, Quebec, Canada
Montreal Neurological Institute Clinical Research Unit
Montreal, Quebec, Canada
CHU de Quebec - Hôpital de l' Enfant Jésus
Québec, , Canada
CCBR - Ålborg - DK
Aalborg, , Denmark
Danish Dementia Research Centre
Copenhagen, , Denmark
CCBR - Vejle - DK
Vejle, , Denmark
Terveystalo Ruoholahti
Helsinki, , Finland
Itä-Suomen yliopisto, Aivotutkimusyksikkö
Kuopio, , Finland
CRST, Clinical Research Services Turku
Turku, , Finland
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, Bas Rhin, France
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, Gironde, France
Hopital Purpan
Toulouse, Haute Garonne, France
Hôpital La Grave
Toulouse, Haute Garonne, France
Hopital Gui de Chauliac
Montpellier, Herault, France
CHU Rennes - Pontchaillou
Rennes, Ille Et Vilaine, France
CHU Nantes - Hopital Nord Laënnec
Nantes, Loire Atlantique, France
CHU Reims - Hôpital Maison Blanche
Reims, Marne, France
CHU Lille - Hopital Roger Salengro
Lille, Nord, France
Hôpital Lariboisière
Paris, Paris, France
CHU de Lyon - Hopital Neurologique Pierre Wertheimer
Bron, Rhone, France
Hôpital des Chapennes
Villeurbanne, Rhone, France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Hôpital Broca
Paris, , France
Studienzentrum fur Neurologie und Psychiatrie
Böblingen, Baden-Wurttemberg, Germany
ISPG - Institut fuer Studien zur Psychischen Gesundheit
Mannheim, Baden-Wurttemberg, Germany
mind mvz GmbH
Stuttgart, Baden-Wurttemberg, Germany
Neuropoint Studienzentrum
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Klinikum Bayreuth GmbH- Hohe Warte
Bayreuth, Bavaria, Germany
Bezirkskrankenhaus Guenzburg
Günzburg, Bavaria, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany
Institut fuer Schlaganfall- und Demenzforschung (ISD)
München, Bavaria, Germany
Neuropraxis Muenchen Sued
Unterhaching, Bavaria, Germany
Neuro Centrum Science GmbH, Geschaftführende Gesellschafterin Barbara Unsorg und Prüfarzt Dr. med. G
Erbach im Odenwald, Hesse, Germany
Neurologische Gemeinschaftspraxis Kassel
Kassel, Hesse, Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, Lower Saxony, Germany
Universitaetsklinikum Aachen AOeR
Aachen, North Rhine-Westphalia, Germany
Neurozentrum Bielefeld
Bielefeld, North Rhine-Westphalia, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, North Rhine-Westphalia, Germany
Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
Siegen, North Rhine-Westphalia, Germany
Klinikum Altenburger Land GmbH
Altenburg, Thuringia, Germany
Emovis GmbH
Berlin, , Germany
Neurologie im Tempelhofer Hafen
Berlin, , Germany
Charite Universitaetsmedizin Berlin - Campus Berlin Buch
Berlin, , Germany
Ospedale degli Infermi
Ponderano, Biella, Italy
Azienda Ospedaliera Card. G. Panico
Tricase, Lecce, Italy
ASST di Monza
Monza, Milano, Italy
Fondazione Istituto G.Giglio di Cefalù
Cefalù, Palermo, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, , Italy
Azienda Ospedaliero Universitaria San Martino
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
AOU dell'Università degli studi della Campania Luigi Vanvitelli
Napoli, , Italy
Azienda Ospedaliera e Universitaria di Perugia
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Fondazione Santa Lucia IRCCS
Roma, , Italy
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , Italy
Research Site
Obu-shi, Aichi-ken, Japan
Research Site
Chiba, Chiba, Japan
Research Site
Chiba, Chiba, Japan
Research Site
Inzai-shi, Chiba, Japan
Research Site
Toon-shi, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kurume-shi, Fukuoka, Japan
Research Site
Aizu-Wakamatsu, Fukushima, Japan
Research Site
Otake-shi, Hiroshima, Japan
Research Site
Asahikawa-shi, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Amagasaki-shi, Hyōgo, Japan
Research Site
Himeji-shi, Hyōgo, Japan
Research Site
Himeji-shi, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kita-gun, Kagawa-ken, Japan
Research Site
Kamakura-shi, Kanagawa, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Tsu, Mie-ken, Japan
Research Site
Togitsu, Nagasaki, Japan
Research Site
Nagaoka-shi, Niigata, Japan
Research Site
Yufu-shi, Oita Prefecture, Japan
Research Site
Kurashiki-shi, Okayama-ken, Japan
Research Site
Okayama, Okayama-ken, Japan
Research Site
Tsukuba, Okayama-ken, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Suita-shi, Osaka, Japan
Research Site
Iruma-gun, Saitama, Japan
Research Site
Kasukabe-shi, Saitama, Japan
Research Site
Shizuka-shi, Shizuoka, Japan
Research Site
Shizuoka, Shizuoka, Japan
Research Site
Bunkyō City, Tokyo-To, Japan
Research Site
Kiyose-shi, Tokyo-To, Japan
Research Site
Kodaira-shi, Tokyo-To, Japan
Research Site
Yamagata, Yamagata, Japan
Brain Research Center
Amsterdam, , Netherlands
Amphia Ziekenhuis, Molengracht
Breda, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Podlaskie Centrum Psychogeriatrii
Bialystok, , Poland
PALLMED Sp. z o.o.
Bydgoszcz, , Poland
Klinika Psychiatrii Doroslych UCK
Gdansk, , Poland
Novo-Med Zielinski i wspolnicy Sp. j.
Katowice, , Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, , Poland
NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
Poznan, , Poland
Neuro-Care Gabriela Klodowska
Siemianowice Śląskie, , Poland
Centrum Medyczne Senior
Sopot, , Poland
Osrodek Badan Klinicznych EUROMEDIS
Szczecin, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Hospital Beatriz Ângelo
Loures, , Portugal
CNS-Campus Neurologico Senior
Torres Vedras, , Portugal
Inha University Hospital
Incheon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Policlinica Gipuzkoa
Donostia / San Sebastian, Guipuzcoa, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
CAE Oroitu
Getxo, Vizcaya, Spain
Hospital del Mar
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Fundacio ACE
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari de Santa Maria
Lleida, , Spain
Complejo Hospitalario Ruber Juan Bravo
Madrid, , Spain
Hospital Victoria Eugenia
Seville, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Skånes Universitetssjukhus
Malmo, , Sweden
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Mölndal, , Sweden
Karolinska Universitetssjukhuset, Huddinge
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Spitalzentrum Biel
Biel/Bienne, , Switzerland
Hôpitaux Universitaires de Geneve- HUG
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Ospedale Regionale di Lugano
Lugano, , Switzerland
Institut fur Regenerative Medizin-IREM Universitat Zurich, Campus Schlieren
Schlieren, , Switzerland
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, , Taiwan
Re:Cognition Health Ltd (London)
London, Greater London, United Kingdom
Charing Cross Hospital
London, Greater London, United Kingdom
The National Hospital for Neurology and Neurosurgery Centre
London, Greater London, United Kingdom
Manchester Royal Infirmary
Manchester, Greater Manchester, United Kingdom
The University of Edinburgh
Edinburgh, Lothian Region, United Kingdom
The RICE Centre
Bath, Somerset, United Kingdom
Queen Elizabeth University Hospital Campus
Glasgow, Strathclyde, United Kingdom
Glasgow Memory Clinic Ltd
Motherwell, Strathclyde, United Kingdom
Ninewells Hospital
Dundee, Tayside Region, United Kingdom
Newcastle University
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-004368-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
221AD304
Identifier Type: -
Identifier Source: org_study_id
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