This study is being done to test a new way of delivering AB-1005 into the brain. The goal is to make the procedure easier and quicker to perform, while providing similar amounts of drug to the part of the brain that needs treatment.
Technical (Stage 0) To test if the new delivery method (prefrontal surgical approach) can consistently deliver AB-1005 to the putamen using MRI monitoring.
Technical (Stage 1) To test if the new delivery method (PIA-based infusion) can consistently deliver AB-1005 to the putamen using brain imaging by MRI.
Technical (Stage 2) To confirm the new delivery method works without brain imaging by MRI, using standard operating room tools including brain imaging by CT.
Safety (Stage 1 and 2) To assess the safety and tolerability of the new delivery method for AB-1005 up to 6 months after surgery
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must be 45 to 75 years of age inclusive, at the time of signing the informed consent.
* \>10 years since diagnosis of PD (at time of consenting / Screening Visit 1)
* Presence of bradykinesia plus any of the following:
* Rigidity
* Resting tremor
* Postural instability
* Modified Hoehn and Yahr stage III-IV in the practically defined OFF state
* Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score \>40 in the practically defined OFF state
* Stable anti-PD medication regimen for at least 4 weeks prior to Screening Visit 1 and through Baseline Visit
* ≥30% reduction in MDS-UPDRS Part III following a levodopa challenge
* Must agree to use barrier method protection when engaging in intercourse/sexual activity with another person for at least 3 months post-dosing.
* Male participants must refrain from donating sperm for at least 3 months post-dosing.
* Female participants cannot be pregnant or breastfeeding at the time of screening. A woman of childbearing potential (WOCBP) must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at the required assessments
* Provision of signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* Provision of signed consent to also participate in LTFU study ASK-PD0-CS002
Exclusion Criteria:
* Evidence of secondary or atypical parkin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Amount of the putamen covered by the drug at the end of infusion, assessed by MRI
Timeframe: immediately after the intervention/procedure/surgery