Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease
Doctors are running a study to find out if a new treatment called NeuroEPO can help people with mild to moderate Alzheimer's disease. The main goals are to see if NeuroEPO can improve or keep people's memory and thinking skills from getting worse, and to check how safe it is. Participants will receive either NeuroEPO or a dummy medicine called a placebo, three times a week for one year. Throughout the study, people will have regular check-ups, blood tests, and memory tests. This helps the researchers understand if NeuroEPO works and what side effects it might have. The study compares NeuroEPO to a placebo to get a clear idea of its effects.
At a glance
What is this study about?
This research is looking into a new treatment called NeuroEPO for people living with mild to moderate Alzheimer's disease. Alzheimer's is a condition that affects memory, thinking, and daily activities. The main aim of this study is to find out if NeuroEPO can help keep these important brain functions stable or even improve them. The scientists also want to make sure that NeuroEPO is safe to use and doesn't cause too many unwanted side effects.
To do this, some people in the study will receive NeuroEPO, which is given into the nose using a small device. Other people will receive a 'placebo' – this looks exactly like NeuroEPO but doesn't contain any medicine. This comparison is really important because it helps the researchers see if any changes are due to NeuroEPO itself, rather than other factors. Taking part involves regular visits to the clinic for tests and check-ups over a year.
This study is a 'Phase 2' trial. This means that NeuroEPO has already had some testing, and now researchers want to learn more about how well it works and its safety in a larger group of people. The hope is that this research could lead to new ways to support people with Alzheimer's disease.
Key takeaways
- This study is for people with mild to moderate Alzheimer's disease.
- It tests a new medicine called NeuroEPO against a placebo (dummy medicine).
- The medicine is given into the nose three times a week for one year.
- The main goals are to check if NeuroEPO helps memory/thinking and if it's safe.
- Participants will have regular clinic visits for tests and check-ups.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, people generally need to be 50 years old or older and have been diagnosed with mild to moderate Alzheimer's disease. Doctors will use specific tests to make sure a person's Alzheimer's is within this range. It's also important that a person's airways (their nose) are clear, as the study medicine is given that way.
Because of the way the medicine is given and the need for regular visits, participants will need to be able to give their agreement to take part (or have a family member or carer do so if they can't). It's also very helpful if a family member or carer is willing to help with the study throughout.
However, some things would mean someone can't join. For example, if they have other serious health problems like certain heart, kidney, or liver conditions, or some types of cancer. Also, if they take blood-thinning medicines, have a history of certain head injuries, or a known allergy to the study drug or similar medicines, they wouldn't be able to participate.
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.
- Are you 50 years old or older?
- Have you been diagnosed with mild to moderate Alzheimer's disease?
- Do you have a clear nose, without constant irritation or runny nose?
- Do you (or your carer) feel able to come to regular clinic visits for a year?
- Do you NOT have certain serious health conditions like severe heart, kidney, or liver problems?
- Do you NOT take certain blood-thinning medications?
What does participation involve?
If you join this study, you will either receive the study medicine, NeuroEPO, or a placebo (a dummy medicine with no active drug) into your nose using a small device. You will receive this treatment three times a week for one year.
Throughout the year, you will need to visit the clinic regularly. These visits will include tests to see how your memory and thinking skills are doing, as well as blood tests to check your general health and see how your body is responding to the treatment. You will have check-ups at the start of the study, and then at 1, 2, 6, and 12 months. Some participants may also be asked if they would like to have special brain scans (called MRI and/or PET scans) at the beginning and end of the study. The total duration of your active participation, including all treatments and visits, will be about one year.
Potential risks and benefits
Locations (1)
- University of SaskatchewanVerified postcodeSaskatoon, Canada
Common questions
What is NeuroEPO?
NeuroEPO is the new medicine being tested in this study for people with Alzheimer's disease. Researchers want to see if it helps their memory and thinking.
What is a placebo?
A placebo is a dummy treatment. It looks exactly like the study medicine but contains no active drug. It helps researchers know if the real medicine is having an effect.
How will I take the medicine?
The medicine (NeuroEPO or placebo) will be given into your nose, three times a week, using a small device.
How long will the study last for me?
Your active involvement in the study, including treatment and clinic visits, will last for about one year.
What kind of tests will I have?
You'll have memory and thinking tests, blood tests, and regular health check-ups. Some people may also have brain scans.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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