A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
This research study is looking into a new medicine called LY3962681, which could potentially help people with Parkinson's disease. The main goals are to find out if this medicine is safe to use, how well people tolerate it, and how it acts in the body. The study has two parts: one for healthy volunteers who receive a single dose, and another for people with Parkinson's disease who receive two doses over several months. The medicine, or a dummy treatment (placebo), is given directly into the fluid that surrounds the brain and spinal cord, called the spinal fluid. Researchers will then closely monitor participants for up to a year to understand its effects. This study is an important first step in developing new treatments for Parkinson's.
At a glance
What is this study about?
This study is an early-stage clinical trial, which means it's one of the first times this new medicine, called LY3962681, is being tested in humans. The main purpose is to see if it's safe and how it behaves in the body, rather than whether it cures a disease. We need to understand its effects thoroughly before it can be studied in larger groups of people.
The study is divided into two main parts. The first part involves healthy volunteers who will receive a single dose of the medicine or a 'dummy' treatment (placebo). This helps us understand basic safety and how the medicine moves through the body in healthy individuals. The second part involves people with Parkinson's disease, who will receive two doses of the medicine or placebo over several months. This allows researchers to see how it affects people living with the condition and if it's well-tolerated over a longer period.
All participants will have the medicine or placebo given directly into the fluid surrounding their spinal cord. This method allows the medicine to get closer to the brain and spinal cord. Researchers will carefully watch all participants for up to a year after their last dose to make sure it's safe and to learn as much as possible about the medicine's effects. This kind of research is vital for developing potential new treatments for Parkinson's disease in the future.
Key takeaways
- This is an early-stage study testing a new medicine for Parkinson's disease.
- It aims to check if the medicine is safe, well-tolerated, and how it acts in the body.
- The medicine or a dummy treatment is given directly into the spinal fluid.
- The study involves both healthy volunteers and people with Parkinson's disease.
- Participants will be carefully monitored for up to one year after receiving the medicine.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you generally need to be between 30 and 80 years old. There are different requirements for the healthy volunteers and those with Parkinson's disease.
If you have Parkinson's disease and are interested in the study, your condition should be fairly stable on your current medicines, and you should be at a specific stage of Parkinson's (Hoehn and Yahr Stage 1 to 2.5 when you're 'off' your medication). You would also need to have specific test results related to Parkinson's, such as an unusual DaT-SPECT scan result and certain findings from your spinal fluid or smell test (for those in the UK/EU).
There are also reasons why you might not be able to join. For example, if you have other serious health problems, especially other brain or nerve conditions beyond Parkinson's (for people with Parkinson's) or any serious illness (for healthy volunteers), you might not be eligible. Also, your weight and body mass index (BMI) need to be within a certain range.
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 30 and 80 years old?
- Do you have a diagnosis of Parkinson's disease (if applying for the Parkinson's group)?
- Is your Parkinson's medication stable (if applicable)?
- Do you not have other serious brain or nerve conditions?
- Is your weight and body mass index (BMI) within the normal range for your height?
- Are you able to attend follow-up appointments for up to a year?
What does participation involve?
If you decide to take part, the study involves two main groups. Healthy volunteers will have one treatment day and then be monitored for up to a year afterwards. People with Parkinson's disease will have two treatment days, spaced 12 to 24 weeks apart, and will also be followed up for up to a year after their second dose.
On a treatment day, you will receive the study medicine, LY3962681, or a placebo (a dummy treatment). This is given as an injection directly into the fluid around your spinal cord, a procedure called an 'intrathecal administration'. This means you'll have a small procedure where a needle is carefully placed in your lower back to deliver the medicine. You will be closely monitored during and after this procedure.
Throughout the study, you'll have regular visits where the study team will carry out various checks and tests. These include physical examinations, blood tests, and other assessments related to your health and, for those with Parkinson's, your symptoms. The exact number of visits and tests will be explained to you in detail by the study team. The total time you'd be involved in the study, including follow-up, could be up to 52 weeks (around one year).
Potential risks and benefits
Locations (16)
- CenExelVerified postcodeEnglewood, United States· Not yet recruiting
- XingImaging LLCVerified postcodeNew Haven, United States· Not yet recruiting
- Aqualane Clinical ResearchVerified postcodeNaples, United States· Recruiting
- Northwestern University Feinberg School of Medicine Dept of NeurologyVerified postcodeChicago, United States· Not yet recruiting
- Quest Research Institute - AlcanzaVerified postcodeFarmington Hills, United States· Not yet recruiting
- University of Pennsylvania, Dept of NeurologyVerified postcodePhiladelphia, United States· Not yet recruiting
- Austin Clinic PPDVerified postcodeAustin, United States· Completed
- Universitätsklinikum DüsseldorfVerified postcodeDüsseldorf, Germany· Not yet recruiting
- Universitätsklinikum MünsterVerified postcodeMünster, Germany· Not yet recruiting
- Ehime University HospitalVerified postcodeTōon, Japan· Recruiting
- Oita University HospitalVerified postcodeYufu, Japan· Not yet recruiting
- P-One Clinic, Keikokai Medical CorporationVerified postcodeHachiōji, Japan· Recruiting
Common questions
What is LY3962681?
LY3962681 is a new medicine being tested to see if it's safe and how it works in the body, particularly for people with Parkinson's disease. It's not yet available outside of this research study.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used in studies to compare the effects of the new medicine against no treatment.
How is the medicine given?
The medicine or placebo is given as an injection directly into the fluid that surrounds your spinal cord and brain. This procedure is called an 'intrathecal administration'.
How long will I be in the study?
Depending on whether you're a healthy volunteer or a person with Parkinson's, your active treatment period will be short (one or two days). However, you'll be followed up for a longer time, up to a year after your last dose.
Can I continue my usual Parkinson's medication?
If you have Parkinson's disease, you will generally continue your usual medications, but they need to be stable. The study doctor will check if your current treatments are suitable for you to join.
How to find out more
Prevail Therapeutics
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.