Evoke Trials

Evoke is a clinical study involving approximately 1840 people from 40 countries worldwide.

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer’s disease. Participants will either get semaglutide or placebo (a “dummy” medicine which does not contain any study medicine) – which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

The purpose of the study is to evaluate the safety and efficiency of oral Semaglutide in people with early Alzheimer´s disease.

What are the benefits of taking part in evoke?

There are several potential benefits of taking part in Evoke such as:

  • Taking a more active role in your own health
  • Getting regular expert medical care at healthcare facilities
  • Having additional talks with the study staff to discuss healthy lifestyle choices
  • Helping others by contributing to medical research

What are the potential downsides?

There may be some potential downsides to taking the study medicine:

  • You may experience side effects
  • Your study medicine may prove to be ineffective in improving the delay of the early stages of dementia
  • The study may require more of your and your study partners time and attention, than normal treatment and may include extra clinic visits or more complex treatment requirements

Before participating in a clinical study such as Evoke, the study doctor or study staff will provide both verbal and written information about the study, including detailed information about the potential risks and benefits, to allow you to make an informed choice about your participation.

Frequently Asked Questions

What will be required if I take part?

Initially, you will go through a screening process to ensure that you meet the criteria for being included in the Evoke study. If you do, your study doctor will explain exactly what is expected of a study participant so you can make an informed decision. Participation in the Evoke study will include:

  • A daily dose of the study medicine, prescribed by the study doctor
  • Attending regular study visits for study-related health checks and examinations
  • Undergoing an MRI or CT scan
  • Undergoing a PET scan or a lumbar puncture test
  • Regular contact with the study nurse or the study doctor throughout the study

Will I know if I have placebo or the study medicine?

Evoke is a “placebo-controlled” study, which, means half of the people in the study will be given a “dummy” medicine called a placebo.

  • You will be randomly assigned to either the study medicine (semaglutide) or the placebo for the full length of the study.
  • You will not know which medicine you have, and neither will your study doctor or the study team.

At the end of the study, you will be told which medicine you were given. You will also have an opportunity to see the results of the study.

How do my personal study results contribute to the final study results?

The information collected from you during the study is made anonymous and entered into a database together with information from everyone else in the study. It is then analysed by doctors and scientists.
For the results to be meaningful, it is very important that everybody in the study continues until the end.

Do I need to attend every study visit?

The Evoke study will last for up to 3 years in order to get a clear understanding of the effects of the study medicine over time. Attending regular study visits will help us to understand the effect of the medicine, as well as giving you the opportunity to discuss any health-related questions or concerns with your study doctor.

Should I still go to my clinic visits if I stop taking the study medicine?

Even if you or your study doctor make the decision to stop taking the study medicine ahead of schedule, it is still very important for you to attend as many visits as possible until the end of the study. Valuable information can still be collected, and the study doctors can monitor your progress and health. Every patient’s information is important for the overall success of the study.

Will being in the Evoke study affect my other medicines?

No, you will continue to take any other prescribed medicines throughout the study as required.

What should I do if I become pregnant during the study?

You should not take part in this study if you are pregnant, breastfeeding, or planning to get pregnant. If you become pregnant during the study, you should stop taking your study medicine immediately and tell the study staff.

Is my personal and medical information confidential?

Your information is protected and treated with confidentiality and will remain anonymous.

Will I get paid?

You will not receive any compensation for time spent at the clinic of for taking part in the study. You may be reimbursed for travel expenses. please speak to the study staff about reimbursement.

Will I be helping others?

Choosing to take part in a clinical study is an important decision. By attending your study visits, you will help us understand how safe the study medicine is, and how well it works. The results from this study will inform treatment for other people with early Alzheimer’s disease.