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- 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
Patrocinador
Hoffmann-La Roche
Fase
Fase 3
Identificador del Ensayo
NCT04339413, WN41874, RENIS IS002966
Afección
Alzheimer Disease
Título Oficial
An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease
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
Todos
No
Criterios de Inclusión
- 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
Criterios de Exclusión
- 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
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Resultados del estudio
LPS WN41874 Open RoAD Final Results December 2023 Argentina Spanish
(PDF, 0.4 MB)
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Para la versión más reciente de esta información por favor vaya a www.investigoxvos.roche.com.ar
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