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A clinical trial to look at the safety and effects of long-term treatment with gantenerumab in people with Alzheimer's disease
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
Neurodegenerative Disorder Alzheimer's Disease (AD)
Basic Details
All
All Ages
No
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT04374253, WN42171, 2020-000766-42
How does the WN42171 clinical trial work?
This clinical trial is recruiting people who have Alzheimer’s disease. In order to take part, patients must have completed one of two previous studies, either study WN29922 or study WN39658.
The purpose of this clinical trial is to measure the long-term safety and effects of gantenerumab for people in these studies. All participants in this study will receive gantenerumab.
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must have been diagnosed with Alzheimer’s disease and you must have taken part in either study WN29922 or study WN39658. You cannot take part if you discontinued study WN29922 or study WN39658 early, or if you received any other experimental treatment for Alzheimer’s disease after finishing one of these studies.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. They will give you all the information you need to make your decision about taking part in the clinical trial.
You may have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently in either study WN29922 or study WN39658, they may not need to be done again.
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 who are not currently pregnant but could become pregnant will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will receive gantenerumab, given as an injection under the skin every two weeks. You will be given treatment in the same way as you received treatment in study WN29922 or study WN39658, meaning that you won’t be able to tell whether you previously received gantenerumab or placebo
Sub-studies
Some people who join this clinical trial may also be able to take part in a ‘sub-study’. This clinical trial currently has two sub-studies, which aim to study two different proteins that are involved in Alzheimer’s disease, known as amyloid and tau.
Patients who participate in the sub-studies will have up to three brain scans (called Positron Emission Tomography, or PET scans) during the study. Before each PET scan, patients will receive an injection with a small amount of ‘tracer’, which binds to particular proteins so that researchers can see them on the PET scan. Patients in the amyloid sub-study will receive one of two tracers, called florbetaben or flutemetamol. Patients in the tau sub-study will receive a tracer called [18F]GTP1.
How often will I be seen in follow-up appointments and for how long?
You will be given gantenerumab every 2 weeks for up to 2 years. Treatment visits will include checks to see how you are responding to the treatment and any side effects that you may be having. You are free to stop this treatment at any time. After being given your last dose, you will have a follow-up appointment with the clinical trial doctor after 2 weeks and then a final visit after about 3 months.
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
Trial-identifier: NCT04374253
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
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For the latest version of this information please go to www.forpatients.roche.com