About Clinical Research

What are clinical research studies and why are they conducted?

Clinical research studies are designed to test the safety and effectiveness of investigational medications. Government agencies require these studies to prove that the medication is safe and effective before it can be prescribed to patients.

Governments have strict guidelines for clinical studies to help ensure that the rights and health of participants are observed while allowing valuable information to be collected about the investigational medication.

What are the phases of clinical research studies?

There are several phases that investigational medications go through:

  • Phase I

    The investigational medication is given to a small group of healthy volunteers to see if it is safe and to monitor how the human body reacts.

  • Phase II

    The investigational medication is given to a larger group of people with the target condition (patients) to determine the appropriate dose and to see if the medication is safe and effective for patients.

    The SUVN-502 Study is a Phase II clinical research study

  • Phase III

    Researchers test the safety and effectiveness of the investigational medication in very large group(s) of patients to further determine if the medication is safe and effective in treating the target condition.

What is informed consent?

The Informed consent process allows you to learn the facts of a clinical research study and if you agree to participate, you can join the study. Before participating, the study team will describe the study and provide you a written document, the Informed Consent Form (ICF), that contains important information about the study for you to consider before you agree to join. During this process, you will have the opportunity to have any questions you have answered by the study doctor.

The ICF document contains study details, what you need to do and what to expect. Known possible risks and potential benefits are also explained. After you have read and discussed all of the information about the study, you can decide whether or not to sign the consent form. This consent form is not a contract and you are always free to leave the study at any time and for any reason, with no penalty to you. Your participation is voluntary.

Why should I join a clinical research study?

Taking part in a clinical study is a big decision and needs to be thought through carefully. Many people take part in clinical trials for different reasons. Some participate to:

  • Gain access to new investigational drugs
  • Receive Study-related medical care
  • Contribute to medical research that may help people in the future

Share this Study

If you know someone (family member or friend) who is considering new treatment options for Alzheimer's disease care, they may be interested in the SUVN-502 study.

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