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

Study Overview
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Brief Summary
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This is an open-label, multicenter, rollover study 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 will be eligible to participate in Part 1 of this study. Of these, participants who complete Week 104 visit in Part 1 will be eligible for Part 2 of this study. Participants will continue receiving 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 (part 2).

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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: Gantenerumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gantenerumab<br>Participants will continue receiving open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) up to Week 208. | Drug: Gantenerumab<br>* Gantenerumab will be administered as SC injection Q4W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Up to 4 weeks after the last dose of study drug (Baseline [Day 1] up to Week 212) | 
| Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score |  | Baseline (Day 1) up to Week 208 | 
| Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) |  | Baseline (Day 1) up to Week 208 | 
| Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI |  | Baseline (Day 1) up to Week 208 | 
| Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab |  | Baseline (Day 1) up to Week 208 | 
| Percentage of Participants with Injection-Site Reactions |  | Up to 4 weeks after the last dose of study drug (Baseline [Day 1] up to Week 212) | 
| Percentage of Participants Who Discontinued Treatment due to AEs |  | Baseline (Day 1) up to Week 208 |