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Un estudio para comprobar si el tratamiento a largo plazo con gantenerumab es seguro en personas con enfermedad de Alzheimer
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
- Trastorno neurodegenerativo
- Enfermedad de Alzheimer (EA)
Tenga en cuenta que el estado de reclutamiento del estudio clínico en su centro puede diferir del estado general del estudio debido a que algunos centros del estudio pueden llevar a cabo el reclutamiento antes que otros.
Estado del estudio:
Terminado
Este estudio clínico se lleva a cabo en
Ciudades
- Aarhus
- Abington
- Akashi
- Albacete
- Amiens
- Amsterdam
- Anjo
- Antofagasta
- Atlanta
- Atlantis
- Austin
- Avon
- Baggiovara
- Barcelona
- Bayamón
- Bellavista
- Berlín
- Białystok
- Birmingham
- Bobigny
- Bolivar
- Boston
- Bradenton
- Braga
- Brescia
- Bron
- Budapest
- Buenos Aires
- Bunkyo City
- Busan
- Changhua County
- Charlotte
- Charlottesville
- Cheltenham
- Chertsey
- Chiba
- Ciudad de México
- Cleveland
- Coimbra
- Columbus
- Creixomil
- Culiacán Rosales
- Córdoba
- Dallas
- Darlinghurst
- Delray Beach
- Dendermonde
- Dundee
- Elche
- Erina
- Fayetteville
- Flowood
- Fort Wayne
- Fukuoka
- Fullerton
- Gainesville
- Gent
- Getxo
- Glasgow
- Goyang-si
- Göteborg
- Hachioji
- Hasselt
- Helsinki
- Henderson
- Himeji
- Hollywood
- Houston
- Incheon
- Inglaterra
- Irvine
- ivanhoe
- Jenkintown
- Kamakura
- Kaohsiung City
- Katowice
- Kazán
- Kishiwada
- Kobe
- Kodaira
- Kogarah
- Koriyama
- Krasnoyarsk
- Kuopio
- Kurashiki
- Köln
- København
- L'Hospitalet de Llobregat
- Las Condes
- Las Vegas
- Leipzig
- Lima
- Lleida
- Logroño
- Lombardia
- London
- Los Angeles
- Lublin
- Madison
- Madrid
- Mainz
- Maitland
- Marseille
- matthews
- Mendoza
- Miami
- Mitaka
- Monterrey
- Monza
- Moscú
- Moskva
- Móstoles
- München
- Münster
- Nagoya
- Nedlands
- New Haven
- New Hyde Park
- New York
- Newcastle upon Tyne
- Newton
- Norfolk
- Norwalk
- Obu
- Ocala
- Odense
- Okayama
- Omaha
- Otake
- Palermo
- Pamplona
- Paraná
- Paris
- Pekín
- Phoenix
- Plasencia
- Plewiska
- Poitiers
- Portland
- Porto
- Porto Alegre
- Pozuelo de Alarcón
- Pozzilli
- Providencia
- Québec
- Raleigh
- Redlands
- Richmond
- Rochester
- Roma
- Rostock
- Sacramento
- Salamanca
- Salt Lake City
- Samsun
- San Sebastián
- Sankt-Peterburg
- Sant Cugat del Vallès
- Santa Ana
- Santander
- Sarasota
- Saratov
- Seongnam-si
- Seoul
- Sevilla
- Sheffield
- Shimotsuke
- Shinjuku City
- Shizuoka
- Simi Valley
- Skåne län
- Solna
- Sopot
- Southampton
- Springfield
- St. Louis
- state-of-parana
- Strasbourg
- Sun City
- Syracuse
- São Paulo
- Taichung City
- Taipei City
- Takamatsu
- Tampa
- Terrassa
- therapeutica
- Tokushima
- Toms River
- Tomsk Oblast
- Torino
- Toronto
- Toulouse
- Toyonaka
- Uji
- Ulm
- Urayasu
- València
- Varsovia
- villa-elisa
- Villeurbanne
- Vilnius
- Washington
- Wellington
- West Vancouver
- Westerstede
- Wichita
- Winston-Salem
- Witten
- Woodbury
- Woodville South
- Wrocław
- Yamagata
- Yoshinogari
- Yoshinogawa
- Zamora
- Zaragoza
- Óblast de Moscú
- Ścinawa
- 横浜市
Identificador del Ensayo:
NCT04374253 2020-000766-42 WN42171
Resumen del estudio
This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.
Hoffmann-La Roche
Patrocinador
Fase 3
Fase
NCT04374253, WN42171, 2020-000766-42
Identificador del Ensayo
Gantenerumab, Gantenerumab
Tratamientos
Alzheimer Disease
Afección
Título Oficial
An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease
Criterios de selección
Todos
Género
Todas las edades
Edad
No
Voluntarios sanos
Criterios de Inclusión
- Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
- The participant should be capable of completing assessments either alone or with the help of the caregiver
- Availability of a person (referred to as the "caregiver")
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of <1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
- Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
Criterios de Exclusión
- Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
- Prematurely discontinued from Study WN29922 or WN39658
- Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
- Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
- Evidence of disseminated leptomeningeal hemosiderosis
- Evidence of intracerebral macrohemorrhage
- Use of prohibited medication
- Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part