A Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants with Alzheimer’s disease.

AN OPEN-LABEL, MULTI-CENTER, ROLL-OVER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF LONG-TERM ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH ALZHEIMER’S DISEASE

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004431-23-ES

Enrollment

175

Registered

2020-02-28

Start date

2020-04-23

Completion date

Unknown

Last updated

2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer’s disease (AD) MedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852

Interventions

Product Name: Gantenerumab Product Code: RO4909832 Pharmaceutical Form: Solution for injection INN or Proposed INN: GANTENERUMAB Current Sponsor code: RO4909832 Concentration unit: g/ml gram(s)/millil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - All participants who completed the OLEs of Studies WN25203 or WN28745 (i.e., latest version of protocol in their countries, and did not discontinue study drug early) are eligible to participate in this study - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 159

Exclusion criteria

Exclusion criteria: - Prematurely discontinued from the OLEs of Studies WN25203 or WN28745 or from study drug for any reason - Any medical condition that the investigator or Sponsor determines 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, by determination of the investigator or Sponsor - Any investigational treatment other than gantenerumab during or since completion of the OLEs of Studies WN25203 or WN28745 - Pregnancy - Evidence of disseminated leptomeningeal hemosiderosis - Evidence of intracerebral macrohemorrhage

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety and tolerability of continued treatment with subcutaneous (SC) gantenerumab at target dose in participants with AD who received gantenerumab in open-label extension (OLEs) of Studies WN25203 or WN28745;Secondary Objective: Not applicable;Primary end point(s): 1. Incidence, nature, severity, and timing of adverse events and serious adverse events 2. Changes from baseline in vital signs, blood tests 3. Changes from baseline in electrocardiogram 4. Changes from baseline in the Columbia-Suicide Severity Rating Scale (C SSRS) 5. Incidence, nature, severity, and timing of magnetic resonance imaging (MRI) safety findings: amyloid-related imaging abnormality–edema/effusion (ARIA E) and amyloid-related imaging abnormality–hemosiderin depositions (ARIA H) 6. Incidence, nature, severity, and timing of injection-site reaction (ISRs) 7. Number and proportion of anti-drug antibody (ADA)-positive and ADA-negative participants during both the treatment and follow-up periods 8. Incidence of treatment discontinuations for adverse events 9. Incidence of adverse events of special interest;Timepoint(s) of evaluation of this end point: 1. Up to 4 weeks after the last dose of the study drug 2. Baseline (Day 1) to 4 weeks after the last dose of the study drug 3. At baseline and unscheduled visit (UV) 4-5. Baseline, Week 24, Week 52, Week 76, Week 104, follow-up (FU)/ early termination (ET) visit, UV 6. Up to 4 weeks after the last dose of the study drug 7. Day 1, Week 52, Week 104, FU/ET visit 8-9. Up to 4 weeks after the last dose of the study drug	—

Measure

Time frame

Main Objective: To evaluate the long-term safety and tolerability of continued treatment with subcutaneous (SC) gantenerumab at target dose in participants with AD who received gantenerumab in open-label extension (OLEs) of Studies WN25203 or WN28745;Secondary Objective: Not applicable;Primary end point(s): 1. Incidence, nature, severity, and timing of adverse events and serious adverse events 2. Changes from baseline in vital signs, blood tests 3. Changes from baseline in electrocardiogram 4. Changes from baseline in the Columbia-Suicide Severity Rating Scale (C SSRS) 5. Incidence, nature, severity, and timing of magnetic resonance imaging (MRI) safety findings: amyloid-related imaging abnormality–edema/effusion (ARIA E) and amyloid-related imaging abnormality–hemosiderin depositions (ARIA H) 6. Incidence, nature, severity, and timing of injection-site reaction (ISRs) 7. Number and proportion of anti-drug antibody (ADA)-positive and ADA-negative participants during both the treatment and follow-up periods 8. Incidence of treatment discontinuations for adverse events 9. Incidence of adverse events of special interest;Timepoint(s) of evaluation of this end point: 1. Up to 4 weeks after the last dose of the study drug 2. Baseline (Day 1) to 4 weeks after the last dose of the study drug 3. At baseline and unscheduled visit (UV) 4-5. Baseline, Week 24, Week 52, Week 76, Week 104, follow-up (FU)/ early termination (ET) visit, UV 6. Up to 4 weeks after the last dose of the study drug 7. Day 1, Week 52, Week 104, FU/ET visit 8-9. Up to 4 weeks after the last dose of the study drug

—

Secondary

Measure	Time frame
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable	—

Countries

Argentina, Australia, Belgium, Canada, Chile, Denmark, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Spain, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

spain.start_up_unit@roche.com+34913257300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026