A clinical trial to look at the long-term effects of gantenerumab in patients with Alzheimer’s disease
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
- Alzheimer's Disease (AD)
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Amsterdam
- Austin
- Baggiovara
- Barcelona
- Basel
- Brescia
- Buenos Aires
- Castellanza
- Chiba
- Elche
- Guadalajara
- Halifax
- Heidelberg
- Incheon
- İstanbul
- İzmir
- Kalamazoo
- Kentville
- Kirov
- København
- Las Condes
- Lombardia
- London
- Los Angeles
- Madrid
- matthews
- Memphis
- Monterrey
- New York
- Newcastle upon Tyne
- Orlando
- Otake
- penarth
- Peterborough
- Poznań
- Québec
- Saint Petersburg
- Samsun
- Seoul
- Sun City
- Tampa
- Terrassa
- The Villages
- Toronto
- Tulsa
- Urayasu
- València
- warrington
- Warszawa
- Woodville South
Trial Identifier:
NCT04339413 WN41874
Trial Summary
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).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04339413 , WN41874
Trial Identifier
All
Gender
No
Healthy Volunteers
1. How does the WN41874 clinical trial work?
This clinical trial is recruiting people who have a type of disease called Alzheimer’s disease. In order to take part, people must have already completed one of the previous gantenerumab clinical trials, which were called WN25203 (SCarlet RoAD) and WN28745 (Marguerite RoAD).
The purpose of this clinical trial is to evaluate the effects, good or bad, of gantenerumab on people with Alzheimer’s disease. In this clinical trial, you will be given gantenerumab only.
2. How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must have already completed one of the previous gantenerumab clinical trials, which were called WN25203 (SCarlet RoAD) and WN28745 (Marguerite RoAD).
You must not have left the previous trial before completion or stopped taking gantenerumab for any reason, and you cannot take part if you are pregnant.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or use contraceptive methods for safety reasons.
3. What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will receive gantenerumab, which is given as an injection under your skin every 4 weeks for 2 years.
4. How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment gantenerumab every 4 weeks for 2 years. You are free to stop this treatment at any time. After being given treatment, you will be seen by the clinical trial doctor 4 weeks after your treatment has stopped. Information for this study will be collected from assessments and tests that your doctor will carry out at each visit.
5. What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov <https://clinicaltrials.gov/ct2/show/NCT04339413>
Trial-identifier: NCT04339413
Trial Summary
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).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04339413 , WN41874
Trial Identifier
Gantenerumab
Treatments
Alzheimer Disease
Condition
Official Title
An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease
Eligibility Criteria
All
Gender
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com