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A clinical trial to look at the effects of gantenerumab on the body in people with early Alzheimer’s disease
A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Neurodegenerative Disorder Alzheimer's Disease (AD)
Basic Details
All
≥50 Years & ≤ 90 Years
No
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Study Identifier
NCT04592341, WN29722, 2020-001384-87
How does the WN29722 clinical trial work?
This clinical trial is recruiting people who have Alzheimer’s disease. In order to take part, patients must have an early form of the disease.
The purpose of this clinical trial is to test the effects, good or bad, of gantenerumab on the body.
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must be 50–90 years of age with early Alzheimer’s disease (also referred to as prodromal or mild) that has been diagnosed from the results of a brain amyloid positron emission tomography (PET) scan. You should also have a person willing to be your ‘study partner’. This person should be someone who knows you well and spends a lot of time with you, such as a spouse, partner or other family member, and who can attend clinic visits with you.
You must not have any condition other than Alzheimer’s disease that affects the central nervous system. You may not be able to take part if you have been previously diagnosed with certain medical conditions.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest 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.
You will 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.
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 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 be given gantenerumab as an injection under the skin of the stomach.
The frequency of injections and the dose of gantenerumab will be gradually increased for up to 9 months until the target dose of 255 mg every week is achieved.
Gantenerumab will be given as follows:
- For the first 3 doses (up to Week 8): 1 injection (120 mg) every 4 weeks
- For the next 3 doses (up to Week 20): 1 injection (255 mg) every 4 weeks
- For the next 6 doses (up to Week 34): 1 injection (255 mg) every 2 weeks
- For the rest of the study (up to Week 103): 1 injection (255 mg) every week
You can also choose to take part in a 2-year extension of the clinical trial, and you will be given gantenerumab for an additional 2 years (up to Week 207): 1 injection (255 mg) every week.
How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment gantenerumab for approximately 2 years (103 weeks). If you take part in the 2-year extension, you will be given gantenerumab for approximately 4 years (207 weeks). You are free to stop this treatment at any time. You are free to stop this treatment at any time.
During the treatment period, you will have regular contact with the study staff, through clinic visits and/or telephone calls. These visits will include checks to see how you are responding to the treatment and any side effects that you may be having.
You will have several PET scans during the trial including at screening (before you start treatment), and at Weeks 52 and 104. If you choose to take part in the 2-year extension of the trial, you will also have PET scans at Weeks 156 and 208. Before these scans, you will receive an injection of a tracer.
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: NCT04592341
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
What you can do next
To find this study again later, copy and save the study number:
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To see if this study is a good fit, talk to your doctor or nurse you trust.
Together, you can look at the For Medical Professional tab and look into your medical history.
Some medical centers in this study offer a contact line. Click "Find participating medical centers" in the map below.
For the latest version of this information please go to www.forpatients.roche.com