#1 Clinical Trials Search in Europe

A study to optimize the delivery of AAV2-GDNF and gadoteridol into the brain for patients with Parkinson’s disease

2 1 1 1

What is this study about?

This study focuses on Parkinson’s Disease, a condition that affects the nervous system and impacts movement. The research aims to investigate the use of a specific method to deliver a gene therapy called AB-1005 directly into a part of the brain known as the putamen. The therapy AB-1005 is a form of AAV2-GDNF, which uses a modified virus to deliver a protein intended to support nerve cells. During the procedure, a substance called gadoteridol may be used as a contrast agent to help with imaging.

The study is conducted in two stages to refine how the medication is delivered. In the first stage, doctors use an MRI, which is a medical imaging technique that uses strong magnets to create detailed pictures of the body, to monitor the delivery in real time. This helps ensure the treatment reaches the correct area. In the second stage, the process is tested using a different surgical setup to see if the delivery can be successful without constant imaging monitoring. The goal is to find the most effective and consistent way to administer the treatment into the brain.

Who Can Join the Study?

  • You must be between 45 and 75 years old at the time you sign the agreement to join the study.
  • You must have been diagnosed with Parkinson’s Disease (a condition that affects movement) for more than 10 years.
  • You must have bradykinesia, which means slow movement, along with at least one of the following: rigidity (muscle stiffness), resting tremor (shaking while at rest), or postural instability (difficulty with balance).
  • Your disease must be at stage III or IV on the Hoehn and Yahr scale (a system used to measure the progression of Parkinson’s) while you are in an OFF state, which means your medication is not currently working to control your symptoms.
  • Your score on the MDS-UPDRS Part III (a test used by doctors to measure motor skills and movement) must be greater than 40 while you are in an OFF state.
  • You must have been taking a stable amount of your Parkinson’s medication for 4 weeks or less.
  • Your symptoms must show at least a 30% improvement on the MDS-UPDRS Part III test after taking levodopa (a common medication used to treat Parkinson’s).
  • You must agree to follow standard contraceptive requirements, which are rules to prevent pregnancy during the study.
  • You must sign the informed consent, which is a formal document where you agree to participate in both the main study and the long-term follow-up period.

Who Cannot Join the Study?

  • Signs of secondary or atypical parkinsonism, which means having symptoms that look like Parkinson’s disease but are actually caused by a different underlying medical condition or a different type of movement disorder.
  • Long-term use of immunosuppressive therapy, which refers to medications that weaken the body’s immune system to prevent it from attacking itself or rejecting a transplant.
  • Having previously received cell or gene therapy, which are treatments that involve adding, removing, or changing genetic material or using living cells to treat a disease.
  • Having abnormal laboratory values, which means blood tests or other medical tests show results that are outside of the healthy or expected range.
  • Having a current or past history of psychosis, a mental state where a person loses touch with reality, or an impulse control disorder, which is a difficulty controlling sudden urges or behaviors.
  • Having depression that is not being treated or is not being managed well enough, specifically measured by a score of 20 or higher on the Beck Depression Inventory (a standard questionnaire used to measure the severity of depression).
  • Having suicidal ideation, which refers to thoughts of self-harm or suicide, as identified by specific questions on the Columbia-Suicide Severity Rating Scale.
  • Having cognitive impairment that is significant enough to affect daily life, measured by a score lower than 25 on the Montreal Cognitive Assessment (a tool used to check memory, attention, and thinking skills).
  • Having a current or past history of malignancy, which is a medical term for cancer, though skin cancers like cutaneous squamous or basal cell carcinomas are allowed.
  • Having any medical reason why you cannot undergo an MRI (a type of medical imaging), surgery, or anesthesia (medication used to prevent pain during surgery), especially while lying face down.
  • The use of PD pump therapies, such as intestinal gel or subcutaneous apomorphine, which are devices or medications used to deliver constant doses of medicine for Parkinson’s disease.
  • Having a history of brain surgery, including deep brain stimulation (DBS), which is a procedure where wires are placed in the brain to help control movement symptoms.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Mazowiecki Szpital Brodnowski Sp. z o.o. Warsaw Poland
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala Katowice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not yet recruiting
30.09.2026

Trial locations

Investigated drugs:

AAV2-GDNF is an experimental gene therapy delivered through an injection into a specific part of the brain. It uses a modified, harmless virus to carry instructions into brain cells, teaching them to produce a specific protein that helps support and protect nerve cells.

Investigated diseases:

Parkinson’s disease – This is a progressive condition that affects the nervous system. It occurs when certain nerve cells in the brain gradually stop working properly. As the condition advances, it typically leads to changes in movement and physical control. The loss of these cells affects the brain’s ability to send signals to the muscles. The symptoms generally worsen over time as the underlying changes in the brain continue.

Trial ID:
2025-522441-21-00
Protocol code:
ASK-PD5-CS202
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study Testing SUL-238 in Patients with Early, Untreated Parkinson’s Disease to Assess Effects on Brain Energy Metabolism

    Recruiting

    2 1
    Investigated diseases:
    The Netherlands

  • Study of IPX203 compared to levodopa/carbidopa in patients with advanced Parkinson’s disease and motor fluctuations

    Recruiting

    3 1 1 1
    Investigated drugs:
    Italy Poland Spain