What happens before joining a trial?

• Before joining a clinical trial, participants are given information about the study and have the chance to ask questions. This process is called informed consent. The purpose of the informed consent process is to make sure participants understand important details about the clinical trial so they can make an informed choice about participating. Informed consent begins prior to agreeing to participate in a trial and continues throughout the study.

How do I know if I can participate in a trial?

• Each clinical trial has specific rules for who can participate, and the rules are different for each trial. These rules may require a certain classification of disease (such as mild, moderate, or severe) or other patient characteristics (such as age range or underlying medical conditions). These rules help to minimize the risks to participants and answer the research questions under investigation. You will go through a screening process to see if you fit the rules for participation. If you do not qualify for one study, another one could be a better fit.

How is participation in a clinical trial different than the standard of care I would receive?

• For Alzheimer’s clinical trials, you will probably need to visit the study doctor more often than you do for your normal care. These frequent visits may go on for a year or more. During the clinical trial, you will have several types of assessments. These may include lab tests, neurologic exams, physical exams, and imaging studies. For example, the study doctor will give some memory tests to see where you are with your thinking and memory and will monitor that throughout the study to see whether any of the interventions have made a difference for you. Please note that the procedures for a specific study may differ, so be sure to follow the instructions provided by your study doctor.

Once I join a trial, can I stop participating?

• Participants may withdraw from a clinical trial at any time, for any reason. No matter the stage of the trial, participants have the right to change their mind. If a study participant decides to withdraw, the study doctor will remove them from the trial in a way that is safe for the participant.

What happens once I complete the trial?

• After your participation has ended, you and your primary doctor should work together to determine the best next steps in your care. The investigational medicine being studied in your trial may need further study in other clinical trials, or it may be reviewed by regulatory agencies such as the U.S. FDA to be approved for use outside of a clinical trial. As a clinical trial participant, you would contribute to the long history of volunteers around the world. Together, trial participants help researchers answer important health questions and discover new medical treatments.

Does someone have to be with me for me to participate in an Alzheimer's clinical trial?

• Most Alzheimer’s clinical trials require a study partner. Study partners for dementia research participants are vital to the research process. Study partners are usually family members or friends, who know the participant very well and usually accompany the participant to study visits. Study partners are integral to the clinical trial conduct—they may assist with informed consent, ensure study compliance, and provide additional perspective on cognitive, functional, and behavioral symptoms.