A hopeful new outlook for  those living  with Parkinson’s disease

A Parkinson’s disease (PD) diagnosis, especially in its early stages, can bring many questions. It’s natural to seek ways to understand the condition and explore potential treatment options. Whether it’s you or someone you care about, gaining a clearer picture of disease progression is crucial, and clinical trials offer a pathway to do just that. The best tool is research. By participating in a clinical trial, individuals with early-stage Parkinson’s can help researchers advance our understanding of the disease and contribute to the development of new treatment strategies.

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How Clinical Trials Work

Thank you for your interest in learning more about Parkinson’s disease clinical trials! Every day, academic institutions, pharmacological organizations and private research facilities across the country are diligently working on making breakthroughs in the study of PD in various clinical trials.

Here’s a look at what a clinical trial for Parkinson’s disease might involve:

A principal investigator, or PI, is the physician in charge of the clinical trial, who is responsible for coordinating, managing and overseeing the clinical study. That individual carries out what is called a protocol.

Protocol is a document that describes how the trial is designed, and outlines how it should be carried out.

Clinical trials, also called research studies or clinical studies, can be either interventional, or non-interventional. Interventional studies mean that they test out an intervention, like a drug, procedure or medical device. Non-interventional studies, also called observational studies, don’t test potential treatments. Instead, researchers observe the participants over a period of time, and track health outcomes.

WHO CAN PARTICIPATE?

Here are the qualifications interested potential participants need to meet in order to join a clinical research study for early Parkinson’s disease:

Are at least 41 years of age, and no older than 80
Have a doctor-confirmed diagnosis of Parkinson’s disease, and experience motor symptoms
Are not currently taking levodopa and are willing to delay starting its use during this study

Learn more about if you or a loved one may be eligible for participation in a PD clinical trial.

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Clinical Trials Make A Difference

Participation in a clinical study provides valuable information that could eventually lead to a better treatment and — with the right breakthrough — to better outcomes. Take our short survey to see if you or a loved one may be a good fit. There is no obligation.

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Understanding Parkinson’s Disease (PD)

Parkinson’s disease is a neurodegenerative disorder of the brain which causes uncontrolled movements such as shaking (tremors), stiffness, and challenges to balance and coordination. Symptoms may begin gradually, but PD’s effects on the central nervous system are chronic (meaning persistent), as well as progressive (meaning they worsen over time). In addition to motor- or movement-related symptoms, patients with PD also experience non-motor symptoms such as cognitive impairment, mood/behavioral issues, sleep disorders, and even GI disruptions like constipation, which can significantly impair quality of life. Some non-motor symptoms can even precede the motor symptoms by several years.^1.

HOW IS IT TREATED?

Although there is no cure for Parkinson’s, there are medicines, surgical interventions and other treatments that may help patients manage some of the symptoms. Currently, the main therapy for Parkinson’s disease treatment is levodopa, which is converted to dopamine in the nerve cells to replenish the brain’s dwindling supply. Though taken in tandem with other drugs to help manage some of its side effects, a frequent unwanted effect of remaining on levodopa for patients can be dyskinesia, or involuntary, writhing, erratic movements of the face, arms, legs or torso. As a result, in recent years many people have turned to clinical trials to shed more light on this condition, and how best to navigate it.^2.

HOPE FOR THE FUTURE

Parkinson’s disease generally affects people aged 60 or over, but it can begin as early as your 30s or 40s in certain patients, so there is a real need for treatment options that don’t solely involve prolonged levodopa reliance. Every day, research teams all across the country are studying new ways to treat PD. That’s why an anti-inflammatory investigational treatment with the ability to reduce inflammation in the brain, and which may help improve motor and non-motor symptoms, would be a potentially significant development. Clinical trials play a key role in determining the efficacy of those novel treatments, and helping to get them to market.

1,000,000

Parkinson’s disease (PD) is the second most common neurodegenerative disease after Alzheimer’s. Nearly 1 million people in the United States have reportedly been diagnosed with PD.^2.

FREQUENTLY ASKED QUESTIONS

What are the symptoms of Parkinson’s disease (PD)?

Signs may include:^1.

Tremors, or involuntary shaking, in hands, arms, legs, head or jaw
Stiffness or contracting of the muscles that may cause pain or limit your range of motion
Slowed movement, called bradykinesia, when walking, getting up out of a chair, etc.
Impaired balance and coordination, sometimes leading to falls
Stooped or slumped posture
Difficulty with speech, handwriting, or with unconscious movements like blinking, smiling, swinging of the arms when walking

1. Source: https://www.mayoclinic.org/diseases-conditions/parkinsons-disease/symptoms-causes/syc-20376055

Who may be a good candidate to apply for an early Parkinson’s disease clinical trial?

You should consider applying for a clinical study if you or a loved one:

Are between the ages of 41-80 years old
Have a clinically-confirmed diagnosis of Parkinson’s disease, and experience motor symptoms
Are not currently taking levodopa and are willing to delay starting its use

What will happen during a clinical trial for Parkinson’s disease?

Most clinical trials will involve frontline screening to confirm that a potential patient is, in fact, a match for that study’s criteria. Once verified and the patient has signed an Informed Consent Form, which clearly provides the details and purpose of the study to that individual and what it involves, participants may expect to attend scheduled appointments at a clinician’s office. They will also receive an investigational medication or placebo and undergo additional screening and regular follow-up monitoring.

Are there any costs to participate in a clinical trial?

In almost all instances, there is no cost to participate in a clinical trial. Participants receive all study-related medical care and medications for the duration of the study at no cost. Likewise in many instances, patients also enjoy benefits such as reimbursement for study-related time and travel.

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