A Clinical Trial In Early Alzheimer’s Disease – The Autonomy Study
Starts in February 2022: A clinical research study to evaluate an investigational medicine in people experiencing problems with memory or trouble thinking.
What is a clinical research study?
A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational medicine or treatment. Clinical trials are conducted by doctors and researchers.
Why is clinical research important?
Clinical research helps doctors and scientists determine if an investigational medicine or therapies are safe and/or effective for use in humans to potentially treat a condition, disease, or disorder.
Research has shown that certain diseases and medications may impact people differently based on their age, gender, and genetic background, including race and ethnicity.
Therefore, clinical studies often require large numbers of diverse volunteers to participate in a single study, sometimes thousands are needed to obtain reliable information.
What is Informed Consent?
“Informed Consent” is a process of information exchange before an adult agrees to participate in research. Potential research participants will be asked to read and sign an Informed Consent document. They will also be given instructions, verbally and in writing, question/answer sessions, and other reading materials to assure the potential study participant’s understanding and willingness to voluntarily enroll in the research.
So before you agree to volunteer for the study, the study doctor or study team is required to explain all the details of the study, which will include the potential risks and potential benefits, and address your questions.
After all of your questions have been answered, and if you wish to participate, then you will sign a document called the Informed Consent Form to ensure:
- You agree to volunteer
- You understand the study, including the study procedures, risks, and potential side effects of the investigational medicine
- You understand that you can leave the study at any time, for any reason.
If you don’t understand what is expected of you or the document, you should continue to ask questions and talk with the study doctor, your family, or others that you trust, until you feel you understand.
What is a placebo?
In clinical research studies, some participants will receive a placebo instead of the investigational medicine. A placebo looks just like the investigational medicine and is given in the same way, but it does not contain any active ingredients. Using a placebo in the study may show the potential differences between the investigational medicine and the placebo. Regardless of whether the investigational medicine works or not, your participation and the results of a study may help us to learn more about early AD.
The study doctor or study team will check additional eligibility criteria during the screening process before you are enrolled into the study and receive the investigational study drug. Study drug can be either the investigational medicine or placebo. Not all individuals will qualify to participate in the research.