A Randomized, Placebo-Controlled, Double-Blind Study of XPro™ in Patients with Early Alzheimer’s Disease with Biomarkers of Inflammation
This research is a 'Phase II' study, which means it's an earlier stage investigation into a new medicine called XPro™. It's for people who have early Alzheimer's disease and also show signs of inflammation in their body. Doctors are trying to find out if XPro™ can help slow down or improve the changes in memory and thinking that happen with early Alzheimer's. Participants will receive either XPro™ or a 'dummy pill' (placebo) without knowing which they are getting. We will be checking memory, thinking, and daily activities over 24 weeks to see if XPro™ makes a difference. This study aims to understand if XPro™ could be a helpful treatment in the future.
At a glance
What is this study about?
This study is looking into a new medicine, called XPro™, for people in the early stages of Alzheimer's disease. We know that inflammation can play a part in Alzheimer's, and this study specifically focuses on people who show signs of this inflammation. The main goal is to see if XPro™ can help improve or stabilize memory and thinking skills over a period of 24 weeks. This is a "Phase II" study, which means it’s still in the earlier stages of drug development, where we are trying to find out if the medicine is safe and if it shows promise.
To make sure the results are as clear as possible, this is a 'randomized, placebo-controlled, double-blind' study. This means that some participants will receive the actual XPro™ medicine, while others will receive a 'dummy pill' (called a placebo) that looks exactly the same but contains no active medicine. Neither you nor your study doctor will know whether you are getting the real medicine or the placebo. This helps us fairly compare how people respond to XPro™ versus not receiving it.
We will be looking closely at changes in memory and thinking abilities, using a series of tests that involve things like remembering shopping lists, numbers, and words. We will also check how well people manage everyday activities and look for any changes in mood or behavior. All these assessments will help us understand if XPro™ has a positive effect.
Key takeaways
- This study explores a new medicine, XPro™, for early Alzheimer's with inflammation.
- It aims to see if XPro™ can improve or stabilise memory and thinking skills.
- Participation involves receiving either XPro™ or a dummy pill (placebo).
- Neither you nor the doctor will know which you are getting.
- The study lasts 24 weeks with regular check-ups and assessments.
- You can stop participating at any time.
Who may be eligible?
This study is looking for both men and women aged 18 years and older. There is no upper age limit, meaning older adults are welcome to participate if they meet other criteria.
To join, you would need to have been diagnosed with early Alzheimer's disease and also show specific signs of inflammation. The study doctors will perform tests to confirm these conditions.
There might be other health conditions or medicines that would prevent someone from joining, but the study team will discuss all the detailed requirements with you to see if this study is a good fit.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years old or older.
- I have been diagnosed with early Alzheimer's disease.
- I have signs of inflammation that the doctors can identify.
- I am able to attend regular clinic visits for 24 weeks.
- I am willing to take either the study medicine or a placebo.
What does participation involve?
If you decide to take part, you would receive either the new medicine, XPro™, or a placebo, which looks identical but has no active ingredient. This would happen over a period of 24 weeks. You would have regular visits to the study clinic during these 24 weeks.
During these visits, you would have various assessments. These include memory and thinking tests, like remembering lists or numbers, and answering questions about your daily activities. There would also be medical checks to monitor your health. The total duration of active participation in the study is 24 weeks, followed by any necessary follow-up.
Potential risks and benefits
Locations (6)
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Common questions
What is 'early Alzheimer's disease with biomarkers of inflammation'?
It means you have mild memory and thinking problems due to Alzheimer's disease, and special tests show signs of inflammation, which can play a part in the disease.
What is a 'placebo'?
A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active drug. It helps doctors see if the treatment really works.
What does 'double-blind' mean?
It means neither you nor your study doctor will know whether you are taking the actual study medicine (XPro™) or the placebo. This helps keep the study fair.
How long will I be in the study?
The main part of the study, where you would receive the medicine or placebo and have regular check-ups, lasts for 24 weeks (about 6 months).
What kind of tests will I have?
You'll have memory and thinking tests, such as remembering shopping lists or numbers, and answer questions about your daily living and overall health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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