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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04241068
• Other study ID #: 221AD304
• Secondary ID: 2019-004368-22
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2, 2020
• Est. completion date: August 28, 2024

Study information

• Verified date: April 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. treatment-naïve participants).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1696
• Est. completion date: August 28, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Aducanumab
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	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	Austin Health	Heidelberg West	Victoria
Australia	KaRa Institute of Neurological Diseases	Macquarie Park	New South Wales
Australia	Australian Alzheimer's Research Foundation	Nedlands	Western Australia
Australia	Royal Melbourne Hospital	Parkville	Victoria
Austria	LKH - Universitaetsklinikum Graz	Graz
Austria	Christian-Doppler-Klinik - Universitätsklinikum Salzburg	Salzburg
Austria	AKH - Medizinische Universität Wien	Vienna
Belgium	AZ Klina	Brasschaat
Belgium	AZ Sint-Jan	Brugge
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven	Leuven
Belgium	AZ Delta	Roeselare
Canada	University of Calgary - Heritage Medical Research Clinic	Calgary	Alberta
Canada	Clinique de la Memoire de l'Outaouais	Gatineau	Quebec
Canada	Institut et Clinique MoCA	Greenfield Park	Quebec
Canada	True North Clinical Research - Halifax Inc.	Halifax	Nova Scotia
Canada	The Medical Arts Health Research Group	Kamloops	British Columbia
Canada	True North Clinical Research	Kentville	Nova Scotia
Canada	St. Joseph's HC- Parkwood Institute	London	Ontario
Canada	Montreal Neurological Institute Clinical Research Unit	Montréal	Quebec
Canada	Bruyere Continuing Care	Ottawa	Ontario
Canada	The Medical Arts Health Research Group	Penticton	British Columbia
Canada	Kawartha Centre - Redefining Healthy Aging	Peterborough	Ontario
Canada	CHU de Quebec - Hôpital de l' Enfant Jésus	Quebec
Canada	Toronto Memory Program (Neurology Research Inc.)	Toronto	Ontario
Canada	Toronto Sunnybrook Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	UBC Hospital	Vancouver	British Columbia
Canada	Medical Arts Health Research Group	West Vancouver	British Columbia
Denmark	CCBR - Ålborg - DK	Aalborg
Denmark	Danish Dementia Research Centre	København
Denmark	CCBR - Vejle - DK	Vejle
Finland	Terveystalo Ruoholahti	Helsinki
Finland	Itä-Suomen yliopisto, Aivotutkimusyksikkö	Kuopio
Finland	CRST, Clinical Research Services Turku	Turku
France	Groupe Hospitalier Pellegrin - Hôpital Pellegrin	Bordeaux Cedex	Gironde
France	CHU de Lyon - Hopital Neurologique Pierre Wertheimer	Bron Cedex	Rhone
France	CHU Lille - Hopital Roger Salengro	Lille Cedex	Nord
France	Hôpital de la Timone	Marseille cedex 05	Bouches-du-Rhône
France	Hopital Gui de Chauliac	Montpellier	Herault
France	CHU Nantes - Hopital Nord Laënnec	Nantes cedex 1	Loire Atlantique
France	Groupe Hospitalier Pitie-Salpetriere	Paris
France	Hôpital Broca	Paris
France	Hôpital Lariboisière	Paris cedex 10	Paris
France	CHU Reims - Hôpital Maison Blanche	Reims	Marne
France	CHU Rennes - Pontchaillou	Rennes cedex 9	Ille Et Vilaine
France	CHU Strasbourg - Hôpital Hautepierre	Strasbourg Cedex	Bas Rhin
France	Hôpital La Grave	Toulouse Cedex 9	Haute Garonne
France	Hopital Purpan	Toulouse cedex 9	Haute Garonne
France	Hôpital des Chapennes	Villeurbanne	Rhone
Germany	Universitaetsklinikum Aachen AOeR	Aachen	Nordrhein Westfalen
Germany	Klinikum Altenburger Land GmbH	Altenburg	Thueringen
Germany	Klinikum Bayreuth GmbH- Hohe Warte	Bayreuth	Bayern
Germany	Charite Universitaetsmedizin Berlin - Campus Berlin Buch	Berlin
Germany	Emovis GmbH	Berlin
Germany	Neurologie im Tempelhofer Hafen	Berlin
Germany	Neurozentrum Bielefeld	Bielefeld	Nordrhein Westfalen
Germany	Studienzentrum fur Neurologie und Psychiatrie	Böblingen	Baden Wuerttemberg
Germany	Universitaetsklinikum Duesseldorf AoeR	Duesseldorf	Nordrhein Westfalen
Germany	Neuro Centrum Science GmbH, Geschaftführende Gesellschafterin Barbara Unsorg und Prüfarzt Dr. med. G	Erbach	Hessen
Germany	Bezirkskrankenhaus Guenzburg	Günzburg	Bayern
Germany	Klinische Forschung Hannover-Mitte GmbH	Hannover	Niedersachsen
Germany	Neurologische Gemeinschaftspraxis Kassel	Kassel	Hessen
Germany	Universitaetsklinikum Koeln	Koeln	Nordrhein Westfalen
Germany	ISPG - Institut fuer Studien zur Psychischen Gesundheit	Mannheim	Baden Wuerttemberg
Germany	Institut fuer Schlaganfall- und Demenzforschung (ISD)	München	Bayern
Germany	Klinikum rechts der Isar der TU Muenchen	Munich	Bayern
Germany	Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung	Siegen	Nordrhein Westfalen
Germany	mind mvz GmbH	Stuttgart	Baden Wuerttemberg
Germany	Neuropoint Studienzentrum	Ulm	Baden Wuerttemberg
Germany	Universitaetsklinikum Ulm	Ulm	Baden Wuerttemberg
Germany	Neuropraxis Muenchen Sued	Unterhaching	Bayern
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)	Brescia
Italy	Fondazione Istituto G.Giglio di Cefalù	Cefalù	Palermo
Italy	Azienda Ospedaliero Universitaria San Martino	Genova
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milano
Italy	Ospedale San Raffaele	Milano
Italy	ASST di Monza	Monza	Milano
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	Ospedale degli Infermi	Ponderano	Biella
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	Azienda Ospedaliera Card. G. Panico	Tricase	Lecce
Japan	Research Site	Aizu-Wakamatsu	Fukushima-Ken
Japan	Research Site	Amagasaki-shi	Hyogo-Ken
Japan	Research Site	Asahikawa-shi	Hokkaido
Japan	Research Site	Bunkyo-ku	Tokyo-To
Japan	Research Site	Chiba-shi	Chiba-Ken
Japan	Research Site	Chiba-shi	Chiba-Ken
Japan	Research Site	Fukuoka-shi	Fukuoka-Ken
Japan	Research Site	Himeji-shi	Hyogo-Ken
Japan	Research Site	Himeji-shi	Hyogo-Ken
Japan	Research Site	Inzai-shi	Chiba-Ken
Japan	Research Site	Iruma-gun	Saitama-Ken
Japan	Research Site	Kamakura-shi	Kanagawa-Ken
Japan	Research Site	Kasukabe-shi	Saitama-Ken
Japan	Research Site	Kita-gun	Kagawa-Ken
Japan	Research Site	Kiyose-shi	Tokyo-To
Japan	Research Site	Kobe-shi	Hyogo-Ken
Japan	Research Site	Kodaira-shi	Tokyo-To
Japan	Research Site	Kurashiki-shi	Okayama-Ken
Japan	Research Site	Kurume-shi	Fukuoka-Ken
Japan	Research Site	Kyoto-shi	Kyoto-Fu
Japan	Research Site	Kyoto-shi	Kyoto-Fu
Japan	Research Site	Nagaoka-shi	Niigata-Ken
Japan	Research Site	Obu-shi	Aichi-Ken
Japan	Research Site	Okayama-shi	Okayama-Ken
Japan	Research Site	Osaka-shi	Osaka-Fu
Japan	Research Site	Otake-shi	Hiroshima-Ken
Japan	Research Site	Sapporo-shi	Hokkaido
Japan	Research Site	Shizuka-shi	Shizuoka-Ken
Japan	Research Site	Shizuoka-shi	Shizuoka-Ken
Japan	Research Site	Suita-shi	Osaka-Fu
Japan	Research Site	Togitsu	Nagasaki-Ken
Japan	Research Site	Toon-shi	Ehime-Ken
Japan	Research Site	Tsu-shi	Mie-Ken
Japan	Research Site	Tsukuba	Okayama-Ken
Japan	Research Site	Yamagata-shi	Yamagata-Ken
Japan	Research Site	Yufu-shi	Oita-Ken
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Netherlands	Brain Research Center	Amsterdam
Netherlands	Amphia Ziekenhuis, Molengracht	Breda
Netherlands	Erasmus Medisch Centrum	Rotterdam
Poland	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 Slaskie
Poland	Centrum Medyczne Senior	Sopot
Poland	Osrodek Badan Klinicznych EUROMEDIS	Szczecin
Poland	Centrum Medyczne NeuroProtect	Warszawa
Poland	NZOZ Wroclawskie Centrum Alzheimerowskie	Wroclaw
Portugal	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
Spain	Fundacio ACE	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba	Córdoba
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	CAE Oroitu	Getxo	Vizcaya
Spain	Hospital Universitari de Santa Maria	Lleida
Spain	Complejo Hospitalario Ruber Juan Bravo	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Policlinica Gipuzkoa	San Sebastian	Guipuzcoa
Spain	Hospital Victoria Eugenia	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
Sweden	Skånes Universitetssjukhus	Malmö
Sweden	Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus	Mölndal
Sweden	Karolinska Universitetssjukhuset, Huddinge	Stockholm
Sweden	Akademiska Sjukhuset	Uppsala
Switzerland	Spitalzentrum Biel	Biel/Bienne
Switzerland	Hôpitaux Universitaires de Geneve- HUG	Genève
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Ospedale Regionale di Lugano	Lugano
Switzerland	Institut fur Regenerative Medizin-IREM Universitat Zurich, Campus Schlieren	Schlieren
Taiwan	Changhua Christian Medical Foundation Changhua Christian Hospital	Changhua
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan City
United Kingdom	The RICE Centre	Bath	Somerset
United Kingdom	Ninewells Hospital	Dundee	Tayside Region
United Kingdom	The University of Edinburgh	Edinburgh	Lothian Region
United Kingdom	Queen Elizabeth University Hospital Campus	Glasgow	Strathclyde
United Kingdom	Charing Cross Hospital	London	Greater London
United Kingdom	Re:Cognition Health Ltd (London)	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	Glasgow Memory Clinic Ltd	Motherwell	Strathclyde
United Kingdom	Newcastle University	Newcastle upon Tyne	Tyne & Wear
United States	Albany Medical College	Albany	New York
United States	Lehigh Center for Clinical Research, LLC	Allentown	Pennsylvania
United States	Emory University Cognitive Neurology Clinic & ADRC	Atlanta	Georgia
United States	JEM Research	Atlantis	Florida
United States	University of Colorado Denver	Aurora	Colorado
United States	Senior Adult Specialty Research	Austin	Texas
United States	McLean Hospital	Belmont	Massachusetts
United States	The Memory Clinic	Bennington	Vermont
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital Department of Neurology	Boston	Massachusetts
United States	Bradenton Research Center, Inc	Bradenton	Florida
United States	IMMUNOe International Research Centers	Centennial	Colorado
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Roper St. Francis Healthcare	Charleston	South Carolina
United States	AMC Research, LLC	Charlotte	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Medical Research Health and Education Foundation, Inc	Columbus	Georgia
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Neurology Clinic, PC	Cordova	Tennessee
United States	UT Southwestern Medical Center	Dallas	Texas
United States	NeuroStudies.net, LLC	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Alexian Brothers Medical Center - Neuroscience Research Institute	Elk Grove Village	Illinois
United States	Yale University	Fairfield	Connecticut
United States	University of Kansas Medical Center Research Institute, Inc.	Fairway	Kansas
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Neurology Center of North Orange County	Fullerton	California
United States	Hattiesburg Clinic, PA	Hattiesburg	Mississippi
United States	Infinity Clinical Research, LLC	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Josephson, Wallack, Munshower Neurology, P.C.	Indianapolis	Indiana
United States	UCI MIND	Irvine	California
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	University of California San Diego Medical Center	La Jolla	California
United States	Senior Clinical Trials, Inc.	Laguna Hills	California
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Empire Neurology, PC	Latham	New York
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Mary S. Easton Center for Alzheimer's Disease Research, UCLA	Los Angeles	California
United States	USC Keck School of Medicine	Los Angeles	California
United States	ActivMed Practices & Research, Inc.	Methuen	Massachusetts
United States	Miami Jewish Health System, Inc	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin
United States	Invicro	New Haven	Connecticut
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Mount Sinai School of Medicine	New York	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	Boston Center for Memory	Newton	Massachusetts
United States	Research Center for Clinical Studies, Inc.	Norwalk	Connecticut
United States	Renstar Medical Research	Ocala	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Accelerated Enrollment Solutions (AES)	Orlando	Florida
United States	Accelerated Enrollment Solutions (AES)	Orlando	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Pacific Neuroscience Medical Group	Oxnard	California
United States	Palm Beach Neurological Center	Palm Beach Gardens	Florida
United States	Stanford Hospital and Clinics	Palo Alto	California
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Penn Memory Center	Philadelphia	Pennsylvania
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Dignity Health	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Donald S. Marks, M.D., P.C.	Plymouth	Massachusetts
United States	Quantum Laboratories Inc.	Pompano Beach	Florida
United States	ActivMed Practices & Research, Inc.	Portsmouth	New Hampshire
United States	Butler Hospital	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Anderson Clinical Research	Redlands	California
United States	National Clinical Research Inc.-Richmond	Richmond	Virginia
United States	Mayo Clinic	Rochester	Michigan
United States	University of Rochester	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
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	University of Washington Medical Centre	Seattle	Washington
United States	California Neuroscience Research Medical Group Inc.	Sherman Oaks	California
United States	Kingfisher Cooperative, LLC	Spokane	Washington
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Meridien Research	Tampa	Florida
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	USF Health Byrd Institute	Tampa	Florida
United States	Advanced Memory Research Inst. of NJ, PC	Toms River	New Jersey
United States	Center for Neurosciences	Tucson	Arizona
United States	Georgetown University Clinical Research Unit (CRU)	Washington	District of Columbia
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Cleveland Clinic Florida - Weston	Weston	Florida
United States	Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.	Wichita	Kansas
United States	Northeastern Pennsylvania Memory and Alzheimer's Center	Wilkes-Barre	Pennsylvania
United States	Gastroenterology Associates of the Piedmont	Winston-Salem	North Carolina
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core Treatment Period: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	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. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.	Up to Week 100
Primary	Core Treatment Period: Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal	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.	Up to Week 100
Primary	Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality-Edema (ARIA-E)	Magnetic resonance imaging (MRI) readings will be used to assess ARIA-E severity as mild, moderate and severe.	Up to Week 100
Primary	Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)	MRI readings will be used to assess severity of ARIA-H microhemorrhages and superficial siderosis.	Up to Week 100
Primary	Core Treatment Period: Number of Participants With Antidrug Antibodies (ADAs) in Serum	Presence of serum ADAs will be determined using a validated assay.	Up to Week 100