Study investigates if semaglutide can prevent the progression of cognition and function
Evoke+ is a clinical study involving approximately 1840 people from 40 countries and is for patients with early Alzheimer's disease. Usage of semaglutide in oral formulation is already approved for the treatment of type 2 diabetes mellitus (T2DM) in several countries. Currently there are no treatments available for the treatment of Mild Cognitive Impairment (MCI) and only symptomatic treatments are available for dementia due to Alzheimer's disease, which therefore signifies the importance of finding a treatment that can target and even prevent the early stages of dementia. The Evoke+ study will examine the effects of semaglutide on the change in cognition and function in people with early Alzheimer's disease.
Key Benefits of Participation:
Taking a more active role in your healthcare
Getting regular expert medical care
Having additional talks with the study staff to discuss healthy lifestyle choices
Helping others by contributing to medical research
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 lumbar puncture test
Regular contact with the study nurse or the study doctor throughout the study.
To see if you may pre-qualify for the study, call Insight Clinical Trials at (216) 526-1843 or fill out this form.
Will I know if I have placebo or the real 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 a database with information from everyone else in the study. It is the analyzed by doctors and scientists. For the results to be meaningful, it is very important the everybody in the study continues until the end.
Do I need to attend every study visit?
The Evoke+ study will last for up to three 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 if 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. In some countries, your personal information may be shared with a search agency. This will only happen if the study staff loses contact with you.
Will I get paid?
You will not receive any compensation for time spent at the clinic or for taking part in the study. You may be reimbursed for travel expenses. Please speak to the study team 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.
To see if you may pre-qualify for the study, call Insight Clinical Trials at (216) 526-1843 or fill out this form.