An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease

TerminadoFase 3ClinicalTrials.gov

ID: NCT04339413Tipo: INTERVENTIONALInicio: 22 de may de 2020Fin estimado: 4 de ene de 2023

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Sexo: ALL

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

Intervenciones

drug

Gantenerumab

Gantenerumab was administered as SC injection Q4W.

Ubicaciones

Instituto Neurologia Bs As

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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