A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer’s Disease (AD), Followed by an Open-Label Extension Period
This research study is looking into a new medicine called Bepranemab for people who have early Alzheimer's disease, specifically those with mild memory and thinking problems. The main goal is to find out if Bepranemab can slow down changes in memory and thinking skills over 80 weeks, compared to a placebo (a dummy treatment). Researchers will also carefully check for any side effects and see how the medicine affects daily activities and overall brain health. This is a "Phase II" study, which means it's an important step in determining if Bepranemab is safe and effective enough to be tested in larger groups of people. Understanding these results could help future treatments for Alzheimer's.
At a glance
What is this study about?
This study focuses on a new medicine called Bepranemab for people in the early stages of Alzheimer's disease. This includes individuals who might have very mild memory or thinking problems (sometimes called 'prodromal' Alzheimer's) or those with already diagnosed mild Alzheimer's.
The main aim of the study is to see if Bepranemab can help slow down the changes in memory and thinking that happen with Alzheimer's, compared to a placebo (a treatment that looks the same but has no active medicine). Researchers will follow participants for 80 weeks, carefully observing how their memory, thinking skills, and ability to do daily tasks change over time. They will use special tools to measure these changes and compare what happens in people taking Bepranemab versus those taking the placebo.
Beyond just memory and thinking, the study will also pay close attention to safety. This means tracking any side effects that people might experience. They'll also look at how Bepranemab affects certain changes in the brain linked to Alzheimer's, using special brain scans. This research is crucial because it helps us understand if Bepranemab is a promising new treatment that could eventually help people living with Alzheimer's disease.
Key takeaways
- This study is testing a new medicine called Bepranemab for early Alzheimer's disease.
- It aims to see if the medicine is safe and can slow down memory and thinking changes.
- Participants will receive either Bepranemab or a placebo for 80 weeks.
- Close medical monitoring and regular assessments will be part of the study.
- The study includes a potential open-label extension where all receive the active medicine.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 or older. There is no upper age limit for taking part. Both men and women are welcome to participate.
The most important factor is that you have been diagnosed with either very early signs of Alzheimer's disease or mild Alzheimer's disease itself. The study is specifically looking for people in these stages to see how the new medicine affects them.
There will be other detailed health checks to make sure the study is safe for you and that the results will be clear. These checks might include specific memory tests, brain scans, and reviews of your overall health.
- I am 18 years old or older.
- I have been diagnosed with very early signs of Alzheimer's or mild Alzheimer's disease.
- My doctors confirm my overall health is suitable for participating in a clinical trial.
- I am able to attend regular study appointments and follow study instructions.
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive either the new medicine, Bepranemab, or a placebo (a dummy treatment that looks identical but contains no active drug). You, your family, and the study doctors wouldn't know which one you are receiving during the main part of the study.
Your participation would involve regular visits to the study clinic over a period of 80 weeks (about 18 months). During these visits, you would have physical examinations, blood tests, and special memory and thinking tests. Some participants might also have brain scans to see how the medicine affects the brain.
After this initial 80-week period, all participants would be offered the chance to continue in an "open-label" extension, where everyone would receive Bepranemab. The total duration of your involvement, including any extension, would be discussed fully before you join.
Potential risks and benefits
Locations (7)
- —Italy
- —Spain
- —Germany
- —Poland
- —Netherlands
- —Belgium
- —France
Common questions
What is Bepranemab?
Bepranemab is a new investigational medicine being tested to see if it can help people with early Alzheimer's disease.
What is a 'placebo' in this study?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine.
How long does the main study last?
The main part of the study, where participants receive either Bepranemab or a placebo, lasts for 80 weeks, which is about 1.5 years.
Will I know if I'm getting the real medicine or the placebo?
No, during the main part of the study, neither you, your family, nor the study doctors will know if you're receiving Bepranemab or the placebo.
Can I leave the study if I want to?
Yes, you are free to leave the study at any time, for any reason, and it will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.