A New Day for People with Parkinson’s Disease
NEULARK is an innovative clinical trial design for people with Parkinson’s disease. The study will evaluate the safety and efficacy of NEU-411, an investigational treatment, for a genetically-defined subset of people with Parkinson’s disease. This study design uses new technologies to track the symptoms and disease progression of participants, while minimizing the burden of participating in a traditional clinical trial.
About Parkinson’s Disease
What is Parkinson’s Disease?
Parkinson’s disease is a complex condition that primarily affects the brain and leads to a range of symptoms. These symptoms can impact your movements (like tremors and muscle stiffness) and have non-movement effects such as depression and sleep problems. Nearly one million people in the U.S. and over 10 million people worldwide are living with Parkinson’s disease, with cases expected to continue to rise.
What is the Genetically-Defined Population?
In some people with Parkinson’s disease, a specific gene called LRRK2 (short for leucine-rich repeat kinase 2) is known to play a key role. People with these changes may not have a family history of Parkinson’s disease, but may still have an overactive LRRK2 enzyme that leads to symptoms. Changes in this gene can cause the enzyme to become overactive. Studies have shown that the degree of overactivity of the LRRK2 enzyme is associated with an individual’s chance of developing Parkinson’s. People with this genetic profile associated with LRRK2 overactivity are described as having, “LRRK2-driven Parkinson’s disease.”
About the Study
The NEULARK study will evaluate the safety and efficacy of NEU-411 in individuals with LRRK2-driven Parkinson’s disease. This clinical trial is designed to investigate whether NEU-411 can potentially slow disease progression.
NEU-411 is taken orally and is designed to inhibit the overactive LRRK2 enzyme. It works by blocking the LRRK2 activity with the goal of slowing down the progression of Parkinson’s symptoms.
By joining the NEULARK study, you will:
- Contribute to vital medical research
- Receive close monitoring and care from a team of specialists
- Potentially benefit from an investigational new treatment targeting LRRK2-driven Parkinson’s disease
Like all clinical trials, there are potential risks. Our team will provide comprehensive information to help you make an informed decision.
Am I Eligible?
Determining your eligibility for the NEULARK study involves a few key steps.
This clinical trial is designed for individuals with LRRK2-driven Parkinson’s disease.
Basic Eligibility Criteria
- Age: Between 40 and 80 years
- Diagnosis: Parkinson’s disease
- Genetic Profile: Positive result of LRRK2-driven Parkinson’s from Neuron23 investigational test
- Health Status: Generally stable health with no expected need for dopaminergic therapy in the next 12 months
Steps to Determine Eligibility
- Initial Screening: Review your medical history and current health status
- Investigational Genetic Test: Confirm the presence of LRRK2-driven Parkinson’s disease
- Medical Evaluation: Undergo a comprehensive medical evaluation to ensure you meet health criteria
Privacy and Data Security
- Your privacy is our priority. We’ve partnered with Sano Genetics to securely gather and handle your data
- You’ll be directed to the Sano Genetics platform to determine your eligibility
- Action: To begin the eligibility process, please click the button below
Clicking the button below will redirect you to the NEULARK Study prescreening system.
Check My EligibilityAbout Research Studies
What Are Research Studies?
Research studies, also known as clinical trials, are carefully designed scientific investigations conducted to answer specific questions. These studies are essential for advancing medical knowledge and improving medical care.
The NEULARK trial is a clinical trial evaluating the safety and efficacy of an investigational drug, NEU-411, in slowing the progression of Parkinson’s compared to a placebo.
Participating in a research study is an opportunity to contribute to medical progress . Your involvement can make a significant difference in the lives of many.
Eligibility for participation in a research study is determined by meeting specific criteria. The study team will thoroughly review your medical history and current health to see if they match the eligibility requirements. They will decide if you qualify to take part in the study. You may also need to share information from your medical records to assist the study team in assessing your eligibility. To determine if you are eligible for the NEULARK study, please review the “Am I Eligible” section.
Frequently Asked Questions
NEULARK is a Phase 2 clinical trial designed to evaluate the safety and effectiveness of an investigational drug, NEU-411, for treating LRRK2-driven Parkinson’s disease.
Eligibility criteria include being between 40 and 80 years old, having a diagnosis of Parkinson’s disease, testing positive for LRRK2-driven Parkinson’s disease, and meeting other health criteria assessed during a screening visit
LRRK2-driven Parkinson’s disease is a genetic profile that is associated with an increase in LRRK2 pathway activity. People with LRRK2-driven Parkinson’s disease may not have a family history of Parkinson’s disease, but may still have an overactive LRRK2 pathway.
Even though LRRK2-driven Parkinson’s disease has the same symptoms as other types of Parkinson’s, the cause may be different. Previous research has shown a link between the level of LRRK2 overactivity and the likelihood that a person develops PD. This overactivity is what we are targeting with specific treatments like NEU-411.
Neuron23 has developed a test that uses genetic techniques to identify individuals that may have an overactive LRRK2 pathway. This test looks at your DNA to find specific changes around the LRRK2 gene that are associated with overactivity of the LRRK2 enzyme.
While Parkinson’s disease may have many different causes, current treatments do not take the individual into consideration. Knowing if you have LRRK2-driven Parkinson’s disease helps to determine your eligibility for this trial of NEU-411 which specifically targets the overactive LRRK2 pathways.
Traditional genetic tests for LRRK2 Parkinson’s disease look for changes in only the LRRK2 gene. The test provided by Neuron23 identifies other genetic changes near the LRRK2 gene that may still lead to overactivity of the LRRK2 enzyme. It is, therefore, possible that you had a negative test for the LRRK2 gene and can still have LRRK2-driven Parkinson’s disease.
NEU-411 is designed to inhibit the overactive LRRK2 enzyme. It works by blocking the LRRK2 enzymatic activity with the goal of slowing down the progression of Parkinson’s. NEU-411 is taken orally and is designed to reach the brain where it produces its effects.
The goal of the NEULARK study is to use precision medicine to treat only those individuals who are most likely to benefit from NEU-411. This means we can focus on providing treatment to those with LRRK2-driven Parkinson’s disease and minimizing unnecessary exposure for others.
A placebo is an inactive substance that looks like an investigational drug but has no therapeutic effect. It is used to compare the effects of the investigational drug and help determine its safety and efficacy.
Clinical trials typically go through four phases. Phase 1 tests safety and dosage, Phase 2 evaluates efficacy and side effects, Phase 3 confirms effectiveness and monitors side effects in a larger population, and Phase 4 gathers additional information after the drug is approved.
Participants will receive regular medical attention and monitoring, and contribute to the advancement of medical research. Taking part in this study may slow the worsening of your Parkinson’s disease if NEU-411 is found to be effective.
Like all clinical trials, there are potential risks, including side effects from the investigational drug. The study team will provide detailed information to help you make an informed decision. You should discuss clinical trial participation with your doctor.
Participant safety is a top priority. The study is conducted by experienced doctors and medical professionals, and it is overseen by governmental health authorities and ethics committees to ensure it is conducted ethically and safely. Participant safety will be monitored using a variety of tests throughout the study.
Yes, participants will receive compensation for their time and travel.
The study team will review your medical history and current health status to determine if you meet the eligibility criteria. You may also need to provide information from your medical records. To determine if you are eligible for the NEULARK study, please review the “Am I Eligible” section.
If you decide to participate, you will go through a thorough screening process to confirm eligibility, followed by a run-in period and then randomization to receive either the investigational drug or a placebo. In addition to doing activities at home, you will have regular visits to the study site for monitoring and follow-up.