Neulark

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 a treatment for people with a newly-defined form of the disease called, “LRRK2-driven 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 LRRK2-Driven Parkinson’s Disease?

In some people with Parkinson’s disease, LRRK2 (short for leucine-rich repeat kinase 2) may play an important role in their condition. Even if you don’t have a family history of Parkinson’s, LRRK2 may still be involved. If you’ve been diagnosed with Parkinson’s disease, testing for LRRK2 can help determine if you’re eligible for the NEULARK clinical trial. When the LRRK2 pathway is overactive, it can lead to damage in the brain that causes Parkinson’s disease symptoms.

About the Study

The NEULARK study will evalute 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 and improve quality of life for people with Parkinson’s disease.

NEU-411 is taken orally and is designed to inhibit the overactive LRRK2 gene. 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 a 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

Basic Eligibility Criteria

  • Age: Between 50 and 80 years
  • Diagnosis: Clinically-established or probable Parkinson’s disease
  • Genetic Marker: Positive result from Neuron23 clinical test
  • Health Status: Generally stable health with no expected need for dopaminergic therapy in the next 12 months or probable Parkinson’s disease
Steps to Determine Eligibility

Steps to Determine Eligibility

  • Initial Screening: Review your medical history and current health status
  • Genetic Testing: Confirm the presence of LRRK2-driven Parkinson’s disease
  • Medical Evalution: Undergo a comprehensive evaluation to ensure you meet health criteria
Privacy and Data Security

Privacy and Data Security

  • Your privacy is our priority. We’ve partnered with a specialized agency to secureely gather and handle your data
  • You’ll be directed to their platform to complete the elibility steps
  • Action: To begin the eligibility process, please click the button below

About 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 effectiveness of an investigational drug, NEU-411, 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

What is the NEULARK Study?

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 50 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 form of Parkinson’s caused by changes in LRRK2 activity that can cause changes in the brain that lead to Parkinson’s disease symptoms.

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 have LRRK2-driven Parkinson’s disease. This test looks at your DNA to find specific changes in LRRK2.

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 certain mutations in your genes.  The test provided by Neuron23 may identify LRRK2-driven Parkinson’s disease even if you’ve had negative genetic testing in the past.

NEU-411 is designed to inhibit the overactive LRRK2 gene. It works by blocking the enzyme activity of LRRK2, with the goal of slowing down the progression of Parkinson’s symptoms. NEU-411 is taken orally and is designed to easily reach the brain where it produces its effects.

The goal of our 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 effective 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 may experience improvements in their condition, though this is not guaranteed. Participants will receive regular medical attention and monitoring, and contribute to the advancement of medical research.

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 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.