AuthorisedTherapeutic exploratory (Phase II)Interventional

Open-Label, Multi Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)

This study is investigating a new way to give a treatment called AB-1005 for Parkinson's disease. It's in an early stage (Phase II), meaning researchers are focusing on making sure the treatment delivery method is safe and finding the best way to give it. They will carefully monitor for any side effects, including specific reactions to the drug itself or reactions related to the surgical procedure used to deliver it. The study also aims to understand how much of the brain area is covered by the treatment and check the accuracy of the delivery. This research is crucial for developing potential new treatments for Parkinson's.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Askbio Inc.

Enrolment target

Start

03 Apr 2026

Parkinson's Disease

What is this study about?

This study is a Phase II clinical trial. This means it's an early stage of research where doctors are mainly focusing on how safe a new treatment method is, and finding the best way to give it. The treatment being looked at is called AB-1005, which is a type of gene therapy designed to help brain cells produce a substance called GDNF that protects them. In Parkinson's disease, the cells that produce dopamine, a chemical essential for movement, are damaged. GDNF is hoped to help keep these cells healthy.

In this study, AB-1005 is being delivered directly into a specific part of the brain called the putamen. Researchers are using a special method to infuse it slowly and precisely. They want to make sure this delivery system works correctly and that the right amount of the treatment reaches the target area. The study also uses a special dye called ProHance, which helps doctors see how the treatment spreads in the brain using MRI scans.

The main goal is to check for any side effects, particularly those related to the treatment itself or the way it's given through surgery. Researchers will also look at how effective the treatment is by checking a range of things like thinking skills, mood, and movement, as well as how the brain responds to the treatment. This research is important because it could lead to new ways to help people living with Parkinson's disease.

Key takeaways

This is an early-stage study (Phase II) for Parkinson's disease.
It's testing a new treatment called AB-1005 given directly into the brain.
The main focus is on safety and finding the best way to deliver the treatment.
Researchers will closely watch for any side effects from the surgery or the drug.
Both men and women aged 18 and over can potentially take part.

Who may be eligible?

To be able to join this study, people need to be at least 18 years old. There's no upper age limit mentioned, meaning older adults could also take part.

Both men and women are eligible to participate in the study. The researchers are looking for a wide range of people with Parkinson's disease to understand how the treatment might affect different individuals.

It's important to remember that these are just the basic requirements. A doctor will need to check other medical details to see if someone is truly suitable for this specific study.

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 at least 18 years old?
Do you have a diagnosis of Parkinson's disease?
Are you male or female?
Are you willing to undergo a surgical procedure?
Are you able to attend several follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive the AB-1005 treatment, which is delivered directly into your brain during a surgical procedure. After the surgery, you would have regular follow-up appointments. These appointments will involve various assessments, including physical examinations, blood tests, and brain scans (MRIs) to see how the treatment is working and to check for any side effects. You might also be asked to complete questionnaires about your mood and thinking skills. The study will last for a specific period, and you'll have ongoing contact with the study team to monitor your health and progress.

Potential risks and benefits

Potential benefits of taking part in this study include gaining access to a new experimental treatment for Parkinson's disease that is not yet widely available. There's a chance this treatment could help improve some of your symptoms, though this is not guaranteed. Potential risks include those associated with the surgical procedure, such as infection or bleeding, and possible side effects from the study drug itself. These side effects can range from mild to serious, and the research team will monitor you closely for them. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is AB-1005?

AB-1005 is a new experimental treatment, a type of gene therapy, being tested for Parkinson's disease.

How is the treatment given?

The treatment is given directly into a specific part of the brain through a surgical procedure.

What is a Phase II study?

A Phase II study is an early stage clinical trial mainly focused on checking the safety of a new treatment and finding the best way to give it.

Will I get better if I join this study?

While the aim is to find new helpful treatments, there's no guarantee that you will personally benefit or get better from participating in the study.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.