A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
This research study is for people aged 40 to 80 who have been recently diagnosed with Parkinson's disease. It's investigating a new medication called NEU-411. This drug is designed to act on a specific genetic pathway, known as LRRK2, which researchers believe plays a role in some cases of Parkinson's. If you have been diagnosed with early Parkinson's and a genetic test shows you have this specific LRRK2 profile, you might be able to take part. The study aims to see how well NEU-411 works compared to a 'dummy' drug (placebo), and to check if it's safe to use. You would take the medication or placebo for about a year, with an option to continue on the active drug afterwards. It's a way to explore new treatments that could help manage Parkinson's disease.
At a glance
What is this study about?
Parkinson's disease is a condition that affects the brain and can cause problems with movement, such as shaking, stiffness, and difficulty with balance. While there are treatments to help manage the symptoms, researchers are constantly working to find new ways to slow down or even stop the disease's progression. This particular study is focusing on a new medication called NEU-411, which works by targeting a specific genetic pathway.
Scientists have found that a gene called LRRK2 can be more active in some people with Parkinson's disease. This study is specially designed for people with early Parkinson's who have this 'LRRK2-driven' type, identified through a genetic test. NEU-411 is a drug that aims to reduce the activity of this LRRK2 pathway. By doing this, researchers hope it might help to protect brain cells and potentially slow down the disease.
This study is in 'Phase 2', which means it's still relatively early in the testing process, but past research has suggested this drug might be helpful. The main goals are to find out if NEU-411 is safe for people to take and if it has any positive effects on the symptoms or progression of Parkinson's disease compared to a placebo (an inactive treatment). The results will help decide if this medication should be studied further in larger groups of people.
Key takeaways
- Targets early Parkinson's disease in those with a specific 'LRRK2' genetic marker.
- Investigates a new medication called NEU-411.
- Aims to check safety and effectiveness compared to a placebo.
- Participation involves regular clinic visits and taking daily medication/placebo.
- The study lasts about a year, with an optional extension.
- Could help find new treatments for Parkinson's disease.
Who may be eligible?
This study is looking for men and women between the ages of 40 and 80. You need to have been diagnosed with Parkinson's disease, and it should be in its early stages. The study specifically focuses on people whose Parkinson's is linked to a particular genetic marker called 'LRRK2'. This will be checked with a special genetic test.
There are also some reasons why you might not be able to join. For example, if your Parkinson's is caused by something other than the usual type, or if you have certain other serious medical conditions like uncontrolled diabetes. The research team will carefully check your health and medical history to make sure the study is a safe and suitable option for you.
Your doctor or the study team will be able to tell you if you meet all the requirements. It’s important to remember that these criteria are in place to ensure the safety of participants and to make sure the study can gather clear and useful information.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 40 and 80 years old?
- Have you been diagnosed with early Parkinson's disease?
- Are you willing to have a genetic test to check for the LRRK2 marker?
- Do you have any other serious uncontrolled medical conditions?
What does participation involve?
If you decide to take part, the study will last for at least 52 weeks (about a year), with a follow-up visit soon after. You might then have the option to continue receiving the active study medication for another 26 weeks.
Firstly, you'll have some health checks and a genetic test to see if you're suitable for the study. If you are, you'll be randomly assigned to either receive the study medication (NEU-411) or a placebo (a dummy pill that looks the same but contains no active drug). You'll take this once a day. Neither you nor the study team will know which you are receiving during the main part of the study. This helps to ensure the results are accurate.
Throughout the study, you'll have regular visits to the clinic for assessments. These will include check-ups, blood tests, and assessments of your Parkinson's symptoms. These visits help the research team keep track of your health, monitor any effects of the medication, and see how your Parkinson's is progressing. You'll always have support from the study team for any questions or concerns.
Potential risks and benefits
Locations (70)
- Banner Sun Health Research InstituteVerified postcodeSun City, United States· Recruiting
- University of ArkansasVerified postcodeLittle Rock, United States· Recruiting
- Neuro-Pain Medical CenterVerified postcodeFresno, United States· Recruiting
- University of California, IrvineVerified postcodeIrvine, United States· Recruiting
- University of California, Los AngelesVerified postcodeLos Angeles, United States· Recruiting
- Esperanza ClinicalVerified postcodeMurrieta, United States· Recruiting
- Parkinson's Research Centers of America - Palo AltoVerified postcodePalo Alto, United States· Recruiting
- Sutter Neuroscience InstituteVerified postcodeSacramento, United States· Recruiting
- University of Colorado - Anschutz Medical CampusVerified postcodeAurora, United States· Recruiting
- Parkinson's Disease and Movement Disorders Center of Boca RatonVerified postcodeBoca Raton, United States· Recruiting
- University of FloridaVerified postcodeGainesville, United States· Recruiting
- Neurology OneVerified postcodeOrlando, United States· Recruiting
Common questions
What is LRRK2 Parkinson's?
LRRK2 Parkinson's is a type of Parkinson's disease linked to a specific change in a gene called LRRK2. The study aims to help people with this specific genetic profile.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the study medication but doesn't contain any active drug. It helps researchers compare the real drug's effects accurately.
How long does the study last?
The main part of the study where you take the medication or placebo lasts for about a year (52 weeks), with an option to continue on the active drug for another 26 weeks.
Will I know if I'm getting NEU-411 or placebo?
During the main part of the study, neither you nor the study doctors will know if you're taking NEU-411 or the placebo. This is to ensure fair and accurate results.
Can I stop participating at any time?
Yes, you are free to leave the study at any point, for any reason. Your decision will not affect your ongoing medical care.
How to find out more
Fatta B Nahab, MD, FAAN, FANA
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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