About Clinical Trials
A clinical trial helps test new ways of treating disease.
Clinical trials are the only way to test investigational medications. All drugs have to be tested in clinical trials before they can be approved by the TGA to treat patients.
There are many different types of clinical trials. The EARLY Trial is a Phase 2b/3 interventional trial, which is looking at the safety and effectiveness of an investigational medication versus placebo (which looks like the investigational medication but contains no actual medicine) in different patient populations and at different dosages. If you are eligible to participate in the EARLY Trial, you will receive tablets, either the investigational medication or placebo. You will join a community of approximately 1650 participants taking part in the trial.
Potential benefits and risks of taking part in the EARLY Trial
There is no guarantee that you will receive any direct benefit from taking part in the EARLY Trial. Potential benefits linked with participating in the EARLY Trial include, you can be part of researching a potential treatment that might benefit people in the future, and you may help us understand how the risk of developing Alzheimer’s disease symptoms changes with different levels of unwanted amyloid proteins.
There are risks associated with taking an investigational medication, because you could experience side effects associated with it. These can range from unpleasant to severe or life- threatening. Not all side effects associated with the investigational medication being taken in this trial are currently known; if new information on side effects for the investigational medication is discovered during your participation in this trial, your trial doctor will tell you about it right away.