Evaluation of long-term safety in parkinsonian patients with intracerebroventricular administration of A-dopamine (anaerobic dopamine) - (DIVE-Follow up)
Parkinson's disease happens when brain cells that make dopamine slowly stop working, leading to tremors, stiffness, and slow movement. Standard dopamine tablets can cause troublesome side effects over time. This clinical trial is testing a new approach called A-dopamine (anaerobic dopamine). Instead of taking pills, this medicine is delivered directly into the fluid spaces inside the brain through a small, surgically placed tube and pump. Because this is an early-stage study, researchers want to see if this method is safe to use over many months and years. They will also look at whether it helps manage Parkinson's symptoms more smoothly throughout the day. The trial is open to adults aged 18 and older who have Parkinson's disease. Participants will have regular hospital visits to check their health, brain function, and overall well-being.
At a glance
What is this study about?
Parkinson's disease is a condition that affects how the brain controls body movements. In a healthy brain, cells produce a chemical messenger called dopamine, which helps your muscles move smoothly. In people with Parkinson's, these cells gradually break down, leading to common symptoms like shaking, muscle stiffness, and difficulty walking.
Most people take tablets such as levodopa to replace the lost dopamine. While these medicines work well at first, their effects can wear off quickly after several years. This can cause 'on-off' swings, where symptoms suddenly return, or cause involuntary jerky movements known as dyskinesia. Delivering dopamine as a pill is also tricky because normal dopamine reacts quickly with oxygen, which can cause irritation or damage.
This trial is testing an innovative solution called A-dopamine (anaerobic dopamine), prepared in an oxygen-free way. It is delivered directly into the ventricles—the natural fluid-filled cavities inside the brain—using an implanted pump. Delivering the medicine straight to where it is needed aims to provide steady, continuous relief without the peaks and valleys of daily pills.
Because this is one of the first times this therapy is being tested in humans, the main goal of this follow-up study is long-term safety. Doctors want to ensure that receiving the medicine directly into the brain over an extended period does not cause unexpected health problems, while tracking how effectively it controls Parkinson's symptoms.
Key takeaways
- The study tests the long-term safety of delivering A-dopamine directly into the brain.
- The treatment uses a small pump to provide steady relief from Parkinson's symptoms.
- It is aimed at adults with Parkinson's, especially those looking for better control than pills provide.
- Because it involves a surgical procedure and a new drug, there are important risks to consider.
- Participation is entirely voluntary and includes regular health and movement checks.
Who may be eligible?
This trial is designed for adults aged 18 and over who have been diagnosed with Parkinson's disease. Because this is a follow-up study looking at long-term safety, it is primarily aimed at patients who have already taken part in the initial DIVE study or are suitable candidates for brain-infusion therapies.
To be considered, participants must generally have Parkinson's symptoms that are no longer well-managed by standard daily tablets. You should also be well enough to undergo the procedures needed to deliver the medicine and be able to attend regular clinic check-ups.
People with other severe medical conditions, certain memory problems, or health issues that make brain surgery unsafe are usually not able to join. The study team will review each person's medical history thoroughly before deciding if the trial is safe and appropriate for them.
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.
- I am aged 18 or older.
- I have a confirmed diagnosis of Parkinson's disease.
- My movement symptoms are difficult to manage with standard oral tablets alone.
- I am well enough to attend regular hospital check-ups and follow-up visits.
- I am open to discussing treatments that involve a surgical pump or infusion device.
What does participation involve?
Taking part in this study involves receiving the study medicine continuously through an internal pump system. Because this requires a surgical procedure to place a small tube into the brain's fluid spaces, your team will guide you through detailed planning and care. Once the system is active, you will attend regular hospital appointments so doctors can adjust the dose and monitor your symptoms. These visits will include physical checks, movement tests, memory and mood assessments, blood tests, and brain scans. Because this is a long-term follow-up study, you may be monitored over several months or years to ensure the treatment remains safe and effective.
Potential risks and benefits
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Common questions
Why is the medicine put directly into the brain?
Putting dopamine directly into the brain allows it to reach the target areas quickly and steadily, avoiding the stomach and bloodstream where normal pills can cause side effects.
Does joining this trial mean I have to stop my other medicines?
Not necessarily right away. Your study doctor will carefully review your current Parkinson's tablets and may gradually adjust your doses as the new treatment takes effect.
Will I have to pay to take part?
No. Clinical trials in the UK do not charge participants for the treatment or assessments. Travel expenses for hospital visits are often reimbursed as well.
Is this a cure for Parkinson's disease?
No. A-dopamine is designed to replace missing dopamine and manage symptoms more smoothly, but it does not cure the underlying condition.
What happens if I change my mind during the study?
You can leave the study at any time. Your medical team will discuss how to safely adjust your care and switch you back to standard treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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