A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

Roche

Status and phase: Terminated; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: Gantenerumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04374253

WN42171

2020-000766-42 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,382 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,382 participants in 2 patient groups

Group 1

Experimental group

Description:

Participants, who completed the double-blind part and did not enter the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the Week 116 visit of Study WN29922 or WN39658. This will be considered the OLE baseline visit (OLE Day 1).

Treatment:

Drug: Gantenerumab

Group 2

Experimental group

Description:

Participants, who completed the double-blind part and the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the OLE Week 34 visit or the final dose visit in the Study WN29922 or WN39658 OLE.

Treatment:

Drug: Gantenerumab