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Participating in a Clinical Trial

Medical research often uses clinical trials in order to find new information about diseases and treatments. Clinical trials are studies that evaluate a medical, surgical, or behavioral intervention.1 It is often used to see if a drug or medical device is safe or effective for people. It can also be used to see if new, potential treatments are more effective than the current standard treatments. Other clinical trials might evaluate screening tools or diagnostic tests, or study aspects of caregiving or coping. Clinical trials are valuable, and without them, new findings, especially with treatments, would be much harder to discover.

Why join a clinical trial?

People participate in clinical trials for a variety of reasons. Some people find it gives them a more active role in their own treatment, while others do it because they hope their participation helps researchers find new information or new treatments for their disease. Deciding to participate in a clinical trial is a personal decision, and it’s not right for everyone. There are often criteria for each trial as to who can join, which may include restrictions on age, stage of disease, type of disease, and any other medical conditions.

What happens when I join a clinical trial?

Each clinical trial is different, but here are some general things that might occur when you a participate in a clinical trial. The staff will explain to you the trial, and get your basic information. You will have the opportunity to ask questions, and then sign an informed consent form. You will then be screened to make sure you’re eligible for the trial.

Once you’re found to be eligible, you will have an initial visit where a baseline evaluation will be done on your cognitive and/or physical skills and abilities, depending on what the trial is for.2 You will then be randomly assigned to the treatment or control group, and the trial proceeds accordingly. You will not know which group you’re in. You will have regular appointments for the treatments or evaluations, and you’ll be monitored closely. This will not take the place of regular doctor’s visits.

A clinical trial tests new treatments, interventions, or medications to prevent, diagnose, or treat a disease.2 Clinical trials have different phases. Phase I trials test whether a potential treatment is safe. Phase II trials further test safety and begin to evaluate how well the treatment may work. Phase III trials are called double-blind, placebo-controlled studies. In these trials, the new treatment is compared to a placebo (an inactive compound, or “sugar pill”) or the new treatment is compared to a standard treatment – this is referred to as a control. The control is important so researchers can know if the new treatment is more effective than the standard treatment. These trials are also “double-blind,” which means the patients and the health professionals administering the treatment do not know whether the patient is receiving the test treatment or the placebo. Avoid bias so the study participants do not influence the results.

Each trial is different, so if you have any questions, it’s best to talk with your contact at the trial or the primary investigator (PI) on the trial. If you ever want to leave the clinical trial, you can do so at any time, with no repercussions. You are not bound to the trial in any way.

Finding a clinical trial

If you’re interested in finding a clinical trial, talk with your doctor or health care provider. You can also go to ClinicalTrials.gov, as well as hospital websites.2 Many universities and research and teaching hospitals do clinical trials. Once you find one that you’re interested in, contact the study coordinator. There is usually some sort of basic screening appointment that will determine whether participating is even an option for you, and any initial questions you have can be addressed.

An honest conversation with your primary provider for your Alzheimer’s disease is important, as a clinical trial might not be the best option for you at this time. Talk with them about whether they think it might be helpful and safe for you, as well as the risks and benefits of participating.