A study to evaluate the safety, tolerability, and efficacy of long-term Gantenerumab administration in participants with Alzheimer's disease (AD)
Study Information
This is an Phase III - Extension study.
Only participants who have successfully completed previous Phase III studies with Gantenerumab can be enrolled (WN29922 or WN39658)
Information about the drug that will be tested in the study
Administration
The drug will be administered via a subcutaneous injection (an injection under the skin) every 2 weeks.
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
All participants will receive gantenerumab:
- Participants who received gantenerumab in the past trial will continue to receive gantenerumab (510mg) every 2 weeks
- Participants who are naive to gantenerumab treatment will receive gantenerumab with gradual up-titration before receiving target dose.)
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the efficacy, tolerability and safety of long-term gantenerumab administration in people with Alzheimer's disease
How long will the treatment last?
Around 4 years
What your involvement will entail?
- During the study, participants will be asked to complete some laboratory tests to evaluate the side effects (it refers to unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
- Complete other tests that will assess their memory, language, functioning, behaviour, quality of life and activities of daily living (i.e. tests or scales like MMSE, ADAS-Cog, CDR, ADCS-ADL …)
- Complete a questionnaire to measure the suicidal behaviour (C-SSRS)
- Participants will have to undergo regular brain scans (MRI) to ensure safety.
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Have successfully completed previous studies with the drug: WN29922 or WN39658
- Be capable of completing assessments either alone or with the help of a study partner
- Agree to remain abstinent or use contraception methods during the treatment period and for at least 16 weeks after the final dose of gantenerumab
- Agree 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.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
- A disease or a condition that may interfere with the safety or study assessments
- Received any investigational treatment other than gantenerumab during or since completion of study WN29922 or WN39658
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
EudraCT Number
2020-000766-42
Clinicaltrials.gov identifier
NCT04374253
Study contact information
Global-Roche-Genentech-Trials@gene.com
Link to full text
https://clinicaltrials.gov/ct2/show/NCT04374253
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on July 2022.
This document has been reviewed by the pharmaceutical company running this trial.
