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Study on the Safety and Effectiveness of NEU-411 for Patients with Early Parkinson's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Parkinson's disease, specifically in its early stages. The study will evaluate a new treatment called NEU-411, which is being developed to help people with a specific type of Parkinson's disease driven by changes in the LRRK2 gene. The purpose of the study is to assess the safety and effectiveness of NEU-411 in participants who have been identified as likely to benefit from this treatment using a special genetic test.

Participants in the study will be randomly assigned to receive either NEU-411 or a placebo. The study will last for about 52 weeks, during which participants will take the medication in the form of a tablet. The study will monitor changes in symptoms and any side effects that may occur. The goal is to see if NEU-411 can improve the symptoms of Parkinson's disease compared to the placebo.

The study uses a special test called the QIAseq Exome Complete System to identify participants who have the LRRK2-driven form of Parkinson's disease. This test helps determine who is most likely to benefit from NEU-411. The study will also track changes in motor and non-motor functions using a scale called the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). This trial aims to provide valuable information about the potential benefits of NEU-411 for people with early Parkinson's disease.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, you will be enrolled in a clinical trial designed to evaluate the safety and effectiveness of a medication called NEU-411 for early Parkinson's disease.
The trial is a Phase 2 study, which means it is focused on assessing the medication's safety and how well it works in people with your condition.
Step 2
Initial assessment
You will undergo an initial assessment to confirm your eligibility. This includes verifying your age, diagnosis of Parkinson's disease, and specific genetic markers using a companion diagnostic test.
Your stage of Parkinson's disease will be assessed using a scale called the Modified Hoehn and Yahr scale, which ranges from 1 to 2.5 for this study.
Step 3
Medication administration
You will be randomly assigned to receive either the NEU-411 tablet or a placebo. A placebo is a tablet that looks like the medication but does not contain the active substance.
The medication is taken orally in the form of a tablet. The specific dosage and frequency will be provided by the study team.
Step 4
Treatment period
The treatment period lasts for 52 weeks. During this time, you will continue taking the assigned tablets as instructed.
Your progress will be monitored regularly to assess any changes in your condition and to ensure your safety.
Step 5
Monitoring and assessments
Throughout the study, you will have regular check-ups to monitor your health and any effects of the medication.
Your motor and non-motor functions will be evaluated using a tool called the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Step 6
End of treatment
At the end of the 52-week treatment period, your condition will be assessed to determine any changes from the start of the study.
The study will also track any adverse events or side effects you may have experienced during the trial.
Step 7
Follow-up
A follow-up period of 2 weeks will occur after the treatment ends, making the total study duration 54 weeks.
This period is to ensure your well-being and to gather final data on the medication's effects.

Who can join the trial?

4 criteria

Aged between 50 and 80 years old at the time of screening.
Have a diagnosis of either clinically established or clinically probable Parkinson's disease. This means a doctor has confirmed or strongly suspects you have Parkinson's disease based on your symptoms and medical history.
Have Parkinson's disease that is LRRK2-driven. This means your Parkinson's disease is linked to a specific genetic factor, which will be checked using a special genetic test.
Have a Modified Hoehn and Yahr (mH&Y) stage of 1 to 2.5. This is a scale used to describe how severe your Parkinson's disease is, with 1 being mild and 2.5 being moderate.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients who have a condition that affects their ability to understand or give consent for the study.
Patients who have a significant psychiatric disorder that is not well controlled.
Patients who have a history of cancer, unless it has been in remission for at least five years.

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, Italy
Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Chieti, Italy

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Investigated drugs

NEU-411 is a medication being tested in this clinical trial for people with early Parkinson's disease. It is specifically aimed at those who have a certain genetic marker related to the disease, known as LRRK2. The purpose of this medication is to see if it can help manage the symptoms of Parkinson's disease and improve the quality of life for those affected. The trial is designed to check both the safety of NEU-411 and how well it works in treating the disease.

What is already known about the treatment

NEU-411 – NEU-411 is administered orally in the form of a tablet and is currently being studied in clinical trials for its potential use in treating early Parkinson's disease. This medication is still under investigation, and its safety and effectiveness are being evaluated in people with a specific genetic form of Parkinson's disease. NEU-411 is designed to help manage symptoms of Parkinson's disease, which is a condition that affects movement and coordination. It works by targeting specific proteins in the brain that are involved in the progression of Parkinson's disease, aiming to slow down or alter the disease process. NEU-411 falls under the category of investigational drugs, as it is not yet approved for general medical use.

Investigated diseases

Parkinson's Disease – Parkinson's Disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease progresses gradually, often starting with barely noticeable tremors in one hand. As it advances, individuals may experience slower movement, muscle rigidity, and impaired posture. Non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment can also occur. The exact cause is unknown, but it involves the degeneration of dopamine-producing neurons in the brain.