Early Signs of Alzheimer’s | About Clinical Trials

Here are some common questions and answers about study participation.

What are clinical research studies (trials)?

Clinical research studies help scientists and doctors explore whether a drug is safe and whether it works. Before a doctor can prescribe a new drug, it must go through several phases of clinical research:
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Phase 1: First study of the drug in people (often healthy volunteers)
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Phase 2: Study of the drug in people with the condition the drug is for
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Phase 3: Study confirming how well the drug works
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Phase 4: More research after the drug is approved

What is informed consent?

Before enrolling in a clinical trial, you and your care partner must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.

What does study participation involve?

Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.

Participation in clinical research studies is your choice, and you may stop at any time

The POLARIS-AD study is a Phase 3 study.

Clinical research studies rely on volunteers. Remember that taking part in the study is your choice. Know that the rules and ethics that doctors must follow to practice medicine also apply to clinical research studies.

If you have additional questions about participating in a clinical research study, contact a study clinic near you.

Overview of Clinical Trials

What are clinical research studies (trials)?

What is informed consent?

What does study participation involve?

The POLARIS-AD study is a Phase 3 study.