Prescriptive Infusion Algorithm (PIA)
Open-Label, Multi-Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months, 10 years
- Procedures mentioned: MRI scans, Infusions, CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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"
- "Participants will receive a one-time infusion of AB-1005 directly into the putamen on each side of the brain."
- "The delivery method will use either MRI or CT scans to guide and check the placement of the infusion needle (cannula, which is a thin tube)."
- "In the LTFU study, participants' health will be monitored for up to 10 years after their surgery."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a new way to deliver AB-1005 into the putamen, a part of the brain that needs treatment. It aims to make delivery easier and quicker, give similar amounts of drug, and check safety for up to 6 months after surgery. It is for adults ages 45 to 75 who have had Parkinson’s disease for more than 10 years.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 45 to 75 years old and have had a Parkinson’s disease diagnosis for more than 10 years.
- Have slow movement plus stiffness, shaking while resting, or trouble with balance.
- When Parkinson’s medicine is not working, have a disease stage of III–IV and a movement test score above 40.
- Keep Parkinson’s medicines stable for at least 4 weeks before screening through the baseline visit.
- Have at least a 30% improvement on a movement test after taking levodopa, a Parkinson’s medicine.
- Agree to use barrier protection, such as condoms, during sexual activity for at least 3 months after treatment. Men must not donate sperm during that time.
- Not be pregnant or breastfeeding at screening. Women who could become pregnant must have negative pregnancy tests when required.
- Sign consent forms, agree to follow study rules, and agree to join the long-term follow-up study.
Who can't join
- Have a different type or cause of Parkinson-like symptoms; serious trouble with thinking or memory; past or current loss of touch with reality or trouble controlling urges; a substance use disorder within 2 years; depression that is not well treated; certain current suicidal thoughts; or any past suicide attempt.
- Have past or current cancer, except treated basal or squamous cell skin cancer, or an active infection, including a scalp infection.
- Have major heart or blood vessel disease or risks, including a stroke, mini-stroke, heart attack, unstable chest pain, or a procedure to restore blood flow within the past year; poorly controlled blood pressure; or poorly controlled diabetes or prediabetes with serious small blood vessel damage.
- Cannot safely have an MRI, general anesthesia, or the required brain surgery; have no safe surgical path to both treatment areas; or have an allergy to treatment ingredients or gadolinium MRI dye.
- Use levodopa/carbidopa gel delivered into the gut, levodopa under the skin, or an apomorphine pump; have had brain surgery, including deep brain stimulation or focused ultrasound; take long-term medicines that weaken the immune system; or have had cell or gene therapy.
- Have screening blood tests outside the study’s limits for blood cell counts, clotting, liver or kidney function, or blood sugar.
- Joined another treatment trial within 12 weeks before screening, or will not avoid new experimental treatments during this study.
- Cannot follow study procedures or attend frequent, lengthy follow-up visits; will not delay vaccines from screening until 1 month after surgery; or have another major issue that the study doctors believe makes participation unsuitable.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 parkinsonism (as determined by the neurologist) * Presence or history of psychosis or impulse control disorder (as determined by the neurologist) * Presence or history (within 2 years prior to screening) of substance use disorder (including alcohol) as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria (or in the judgment of the neurologist) * Presence of untreated or sub optimally treated depression (Beck Depression Inventory \[BDI\]-II score ≥20) * Current suicidal ideation as indicated by positive response to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C SSRS), or any history of a suicide attempt * Clinically significant cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<25) * Presence or history of malignancy other than treated cutaneous squamous or basal cell carcinomas * Presence of clinically active infection, including acute or chronic scalp infection * Known contraindications to MRI * Presence or history of significant cerebrovascular or cardiovascular disease, including: * Stroke, transient ischemic attack, or other suspected cerebrovascular accident within 1 year prior to screening * Unstable angina pectoris or myocardial infarction within 1 year prior to screening * Revascularization procedure(s) within 1 year prior to screening * Poorly controlled hypertension, poorly controlled diabetes mellitus or prediabetes mellitus with known significant microvascular injury, or other significant cardiovascular history or risk factor * Known history of complications of anesthesia including difficult airway management and/or difficult endotracheal intubation, malignant hyperthermia, or other related issues that would compromise participant safety during general anesthesia (as determined by the anesthesiologist) * Inability to identify a safe trajectory to each putamen via an occipitoparietal entry point, or known contraindications to brain surgery in prone position (as determined by the neurosurgeon) * Known allergy or sensitivity to ingredients in the intervention formulation and/or to gadolinium-based contrast agents * Concurrent use of percutaneous levodopa/carbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump * History of brain surgery (including deep brain stimulation \[DBS\] or focused ultrasound) * Chronic immunosuppressive therapy * History of prior cell or gene therapy * Participation in other interventional clinical trials within 12 weeks prior to screening or unwilling to refrain from starting new investigational agents throughout the course of the study * Laboratory values at screening: * Platelets ≤100,000/mm3 * PT \>15 s, aPTT \>40 s, and/or INR \>1.3 * Absolute neutrophil count (ANC) ≤1500/mm3 * Hemoglobin ≤10.0 g/dL * Aspartate aminotransferase or alanine aminotransferase ≥2.5 times the upper limit of normal * Total bilirubin ≥2.5 mg/dL * eGFR \<45 mL/min/1.73 m2 * HbA1C ≥8% * Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments (during LTFU study ASK-PD0-CS002) * Unwilling to defer any vaccination from screening through 1 month after surgery * Any significant issue raised by the neurologist, neurosurgeon, or anesthesiologist that may make a participant unsuitable for the study
Study sites (4)
OH
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106Stacy Pot · Study contact · 216-844-5605 · stacy.pot@uhhospitals.orgCamilla Kilbane, MD · Principal investigatorMore trials in Cleveland
- The Ohio State University Wexner Medical Center Neurological Surgery · Columbus, OH 43210Andrea Davis · Study contact · 614-814-6871 · andrea.davis@osumc.eduBrad Elder, MD · Principal investigatorMore trials in Columbus
PA
- University of Pittsburgh Medical Center · Pittsburgh, PA 15213Sherry Mosovsky, MPH · Study contact · 412-692-4659 · mosovskysl@upmc.eduValerie Suski, MD · Principal investigatorMore trials in Pittsburgh
SC
- Medical University of South Carolina · Charleston, SC 29425Sandra Wilson · Study contact · wilsosan@musc.edu · Study contact · (843)-792-4616Christine Cooper, MD · Principal investigatorMore trials in Charleston