A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer´s disease (EVOKE plus)
This important study is testing a tablet called semaglutide for people in the early stages of Alzheimer's disease. This includes those with mild memory problems or very mild dementia. Participants will take either the study tablet or a dummy tablet (placebo) every day, without knowing which one they have. Researchers will carefully check their memory and thinking skills over approximately two years to see if the tablet helps. They will also make sure the treatment is safe. The aim is to understand if semaglutide could be a new way to help people living with early Alzheimer's.
At a glance
What is this study about?
This study, called EVOKE plus, is exploring a new tablet treatment for people who are just starting to show signs of Alzheimer's disease. This might be if you've been told you have "mild cognitive impairment" (meaning mild memory or thinking problems) or very early Alzheimer's dementia.
The medication being tested is called semaglutide, which is already used for other health conditions. In this study, it's being given as a tablet. The main goal is to find out if taking this tablet can slow down the changes in memory and thinking that happen with early Alzheimer's. Researchers will regularly assess participants' thinking abilities over about two years using a special rating scale. They also want to make sure the treatment is safe and doesn't cause too many side effects.
This is a "Phase III" study, which means it's a large, detailed study. It's designed to give clear answers about whether semaglutide could become a helpful treatment option for people with early Alzheimer's. Participants will either receive one of a few different strengths of the semaglutide tablet or a 'placebo' tablet, which looks the same but contains no active medicine. This helps researchers fairly compare the effects of the actual drug against no active treatment.
Key takeaways
- This study is testing a tablet called semaglutide for early Alzheimer's disease.
- It aims to see if the tablet can slow down memory and thinking changes.
- Participation involves taking a tablet daily and regular clinic visits over about two years.
- You might receive the active drug or a placebo (dummy tablet).
- Close medical monitoring of your health and memory will be provided.
- You can stop participating at any time you wish.
Who may be eligible?
This study is looking for a wide range of adults, aged 18 and over, both men and women, who have been diagnosed with early Alzheimer's disease. This includes people who have been told they have mild cognitive impairment (mild memory or thinking problems) or mild dementia, both specifically linked to Alzheimer's disease.
To be considered for this study, your doctor would need to confirm that your memory or thinking changes are indeed due to early Alzheimer's. There will be other specific health checks to make sure the study is a good fit for you and that taking the medication would be safe.
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 18 years old or older?
- Have you been diagnosed with mild memory problems (mild cognitive impairment) or mild dementia?
- Has your doctor confirmed that these memory or thinking changes are due to early Alzheimer's disease?
- Are you able to take a tablet every day as prescribed?
What does participation involve?
If you join this study, it would involve regularly taking a tablet every day for about two years. You would visit the clinic regularly for assessments. These visits would include checks of your memory and thinking skills, likely through questionnaires and simple tests. You would also have general health checks, such as blood tests, to monitor your well-being and make sure the medication is safe for you. The total duration of your active participation, including follow-up assessments, would be around two to three years.
Potential risks and benefits
Locations (21)
- —UnverifiedRomania
- —UnverifiedBulgaria
- —UnverifiedBelgium
- —UnverifiedCroatia
- —UnverifiedFrance
- —UnverifiedGreece
- —UnverifiedHungary
- —UnverifiedSlovakia
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedAustria
- —UnverifiedNetherlands
Common questions
What is semaglutide?
Semaglutide is a medication that's being tested to see if it can help people with early Alzheimer's disease. It's already approved for other health conditions.
What does 'mild cognitive impairment' mean?
It means you have mild problems with your memory or thinking, which are worse than expected for your age but not severe enough to be called dementia.
What is a 'placebo'?
A placebo is a tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare how well the actual drug works.
How long will the study last?
Your active participation, including taking the medication and having regular check-ups, will last for about two years. There might be some follow-up appointments after that.
Can I leave the study at any time?
Yes, you are completely free to withdraw from the study at any point, for any reason, and it will not affect your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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