Parkinson's Clinical Trial Companion Navigating Clinical Trials | Page 23

lower Parkinson’s risk, and now scientists are testing their safety and efficacy. Many trials require participants who have been recently diagnosed and often not yet treated with PD medications. (Researchers refer to this as de novo Parkinson’s.) Some studies do allow people who are taking certain PD drugs, and each trial sets specific criteria. With many in the early years of PD keeping a low profile or unaware of studies that need volunteers, though, these trials often struggle to enroll enough participants. Even so, trials of disease-modifying therapies aren’t right for everyone. Because of the nature or severity of symptoms, some people need to start medication right away. Others don’t like the idea of possibly receiving a placebo. (Many trials are placebo-controlled, meaning one group of participants takes placebo for comparison to the group on the investigational therapy.) Either way, newly diagnosed people can still make many valuable contributions to PD research. Treating Early Symptoms People are diagnosed with Parkinson’s based on the cardinal motor symptoms: tremor, rigidity and slowness of movement. Other non-motor symptoms, such as depression and constipation, can arise even before these movement changes. There are many clinical studies testing therapies for these symptoms — both motor and non-motor. Some clinical trials do not test new drugs. Remember fact 2: There Is a Study (or Several) for You. For example, you could take part in an exercise trial for fatigue or a study of cognitive behavioral therapy for mood changes. And not all trials in early Parkinson’s require people who have not yet started medication. A non-motor symptom study, for example, may not ask participants to change their motor symptom medications. Learning about Disease Onset and Progression Knowing Your Options Early On People early in their Parkinson’s also can teach scientists a lot about the disease. We have much to learn about why and how Parkinson’s starts, and recently diagnosed volunteers can help. Participating in a study over time also allows researchers to study how Parkinson’s progresses. This information can help us learn how to predict an individual’s disease course and develop and test new treatments to stop its progression. If you’ve recently been diagnosed with PD, you may want to think about the benefits and risks of research participation and find out what studies are available to you before you start medication, particularly if your symptoms are mild. You can then have an informed, thoughtful discussion with your doctor to help decide what’s best for you. Studies that help us learn about disease onset and progression — and do not test a new treatment — are called observational studies, and they come in many shapes and sizes. As part of an observational study, you might undergo a brain imaging scan to look for changes that could diagnose and track disease progression (i.e., biomarkers), complete online questionnaires about your symptoms to see how your disease changes over time or fill out one-time surveys to see if you’ve been exposed to certain risk factors. Or, you may give skin cells that scientists turn into dopamine cells to study Parkinson’s “in a dish” — another way to look at what goes wrong in PD (and identify potential drug targets). Some observational studies need brain tissue to help researchers understand hows and whys of PD. While something like brain donation may not cross your mind until later in life or well into your journey with Parkinson’s, people both with and without PD can consider this at any time. When brain tissue is coupled with information on your symptoms and disease experience, it is often even more beneficial to researchers, so thinking about this earlier rather than later is important. (See “Donating Brain Tissue to Research,” pg. 24.) Remember fact 1: Patients Are Key Research Partners. Many physicians, especially if their practice is geographically remote from clinical trials, may not bring up research participation. In a 2014 Harris Poll conducted on behalf of MJFF and pharmaceutical company AbbVie, only one in 10 doctors said they talked about research frequently with their patients. Time constraints may prevent these conversations, especially when providers focus primarily on care as opposed to research. Yet people with Parkinson’s say they look to their doctors for information on research and opportunities to participate. See “How Do You Get Involved in Parkinson's Research?" pg. 15, for tips on talking to your physician and learning about available trials. The key is knowing your options early on so you can make an informed decision. Early in the disease course — a time that can be overwhelming — research participation is a way many find they are able to gain the upper hand on their disease and make a difference. Chapter 2 — Research Participation throughout Your Parkinson’s Journey 21