Clareo Health | A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Participants who were in the active arm in the double blind part and those who have completed OLE part in the parent study, will continue receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W). Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme as in the parent study before receiving target dose of open label gantenerumab.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
