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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)
Detalles básicos
Patrocinador
Hoffmann-La Roche
Fase
Fase 3
Identificador del Ensayo
NCT04374253, WN42171, 2020-000766-42
Afección
Alzheimer Disease
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
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.
Criterios de selección
Todos
Todas las edades
No
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
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 WN42171 POSTGRADUATE Final Results January 2024 Spanish
(PDF, 0.3 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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