Buscar centros médicos participantes y el estado actual del estudio en cada uno de ellos
-
Inicio
-
Buscador de ensayos clínicos
- Open RoAD
Un estudio para analizar si gantenerumab era seguro para su uso a largo plazo en personas con enfermedad de Alzheimer (Open RoAD)
Estudio para evaluar la seguridad y la tolerabilidad de la administración de gantenerumab a largo plazo a participantes con enfermedad de Alzheimer
Trastorno neurodegenerativo Enfermedad de Alzheimer (EA)
Detalles básicos
Resumen del estudio
The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.
Criterios de selección
- Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study
- Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study
- For Part 1 and Part 2:
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
- Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
- Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant
- Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason
- Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
- If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest
- Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745
- Pregnancy
- Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
- Evidence of intracerebral macrohemorrhage
- Part 2: Participants who have been discontinued from Part 1 of the study
La siguiente información proviene de la página web ClinicalTrials.gov a disposición del público y ha sido editado por laicos.
La siguiente información se origina en el sitio web ClinicalTrials.gov a disposición del público y no ha sido modificado.
Resultados
Explorar estudios relacionados
Resultados del estudio
LPS WN41874 Open RoAD Final Results December 2023 Argentina Spanish
(PDF, 0.4 MB)
Explorar estudios relacionados
Para la versión más reciente de esta información por favor vaya a www.investigoxvos.roche.com.ar
Comparte este estudio
Link to Pagemediante el uso de una de estas opciones
¡Copiado al portapapeles!