A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer´s disease (EVOKE)
This research study, called EVOKE, is looking into a new tablet medicine called semaglutide (also known as Rybelsus) for people in the early stages of Alzheimer's disease. This includes individuals with mild memory problems or mild dementia linked to Alzheimer's. The study aims to find out if this medicine can help slow down the changes in thinking and memory that happen with Alzheimer's disease. Researchers will also be checking carefully to make sure the medicine is safe to use. Some participants will receive the active medicine, while others will receive a dummy pill (placebo) to help compare the effects fairly. The study will last for about two years, with regular check-ups.
At a glance
What is this study about?
This research study, called EVOKE, is designed to investigate a new tablet medicine for people who have been diagnosed with early stages of Alzheimer's disease. This includes individuals experiencing mild changes in their memory and thinking skills, or those with very mild dementia that doctors believe is caused by Alzheimer's.
The medicine being tested is called semaglutide, which is already approved for other conditions. Researchers want to see if it can also help people with Alzheimer's disease. They will be carefully watching to see if the medicine helps improve or maintain memory and thinking abilities, and if it affects daily activities like getting dressed or managing household tasks.
This is a 'Phase III' study, which means it's a large, important step in testing new medicines. To make sure the results are fair, some people will receive the actual semaglutide tablets (in different strengths), and others will receive a 'placebo' – a dummy tablet that looks the same but contains no medicine. Neither the participants nor their doctors will know who is getting which tablet until the study ends. This helps researchers understand the true effects of the medicine.
Key takeaways
- Tests a new tablet medicine (semaglutide) for early Alzheimer's.
- Aims to see if it helps with memory and thinking.
- Compares the medicine to a dummy pill (placebo).
- Involves regular clinic visits and health checks over two years.
- For people aged 18 and over with mild cognitive impairment or mild dementia due to Alzheimer's.
Who may be eligible?
The study is looking for both men and women, aged 18 and older, who have been diagnosed with certain early forms of Alzheimer's disease. This includes people with mild memory problems or very mild dementia that doctors believe is due to Alzheimer's.
To be considered for this study, you would need to have had a recent diagnosis of mild cognitive impairment (MCI) or mild dementia, both of which are related to Alzheimer's disease. Your doctors would confirm these specific diagnoses based on certain medical criteria.
There might be other health conditions or medications that would prevent someone from joining, as the researchers need to make sure the study is as safe as possible for everyone involved. Your doctor would help determine if you meet all the specific requirements.
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 (MCI) linked to Alzheimer's?
- Or have you been diagnosed with very mild dementia linked to Alzheimer's?
- Are you able to take a tablet medicine every day?
What does participation involve?
If you join this study, you would take a tablet every day, either the study medicine (semaglutide) or a dummy pill (placebo), for about two years. You would have regular visits to the clinic, starting from when you first join and continuing every few months up to week 104 (about two years). These visits would involve memory and thinking tests, and doctors would check your overall health.
The main way researchers will measure if the medicine is working is by a specific scoring system that measures how well you remember things and handle everyday tasks. They will also look at how your daily activities are affected and track your progress over time.
After the main two-year period, some participants might be followed up for a bit longer, up to an extra year, to see how they are doing in the long term. Throughout the study, you would have medical check-ups to make sure you are safe and well.
Potential risks and benefits
Locations (21)
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedRomania
- —UnverifiedPortugal
- —UnverifiedHungary
- —UnverifiedIreland
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedGreece
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedPoland
Common questions
What is semaglutide?
Semaglutide is a medicine that is being tested to see if it can help people with early Alzheimer's disease. It's normally used for other health conditions.
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 researchers compare the effects fairly.
How long will the study last?
The main part of the study involves taking the tablet and having check-ups for about two years (104 weeks). Some follow-up might continue for an additional year.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctor will know whether you are receiving the active medicine or the placebo until the study has finished. This helps to keep the study fair.
What kind of tests will I have?
You'll have regular check-ups, including simple tests to check your memory and thinking skills, and doctors will assess your overall health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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