Prescriptive Infusion Algorithm (PIA) for Parkinson's Disease

This study is testing a new way to deliver AB-1005 directly into the brain for people with Parkinson's disease. The goal is to make the procedure for delivering AB-1005 easier and faster, while still getting the right amount of the drug to the part of the brain that needs it. You might be able to join if you are 45 to 75 years old, have had Parkinson's disease for over 10 years, and experience symptoms like slow movement (bradykinesia), stiffness (rigidity), or tremor. The main way we'll know if the new delivery method is successful is by checking with an MRI scan how much of the target brain area (putamen) is covered by AB-1005 right after the procedure. The study is currently recruiting a small number of participants.

Study design: This is an interventional study with a planned enrollment of 18 participants. It is an open-label study, meaning both you and the doctors will know you are receiving AB-1005.
What's involved: You will undergo a one-time surgical procedure under general anesthesia to receive AB-1005. The procedure involves delivering the drug into your brain using a special technique.
Compensation: Not stated in the trial record.
Follow-up: After the initial follow-up period, all participants will continue into a long-term follow-up study for up to 10 years after their surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Prescriptive Infusion Algorithm (PIA)

Not Yet Recruiting

PHASE2Ages 45–75InterventionalTreatment

AskBio Inc

~18 participants

Updated 2026-07-27 on ClinicalTrials.gov

What's tested:Prescriptive Infusion AlgorithmAB-1005

At a glance

Recruiting sites

0 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Amount of the putamen covered by the drug at the end of infusion, assessed by MRI

Measured over immediately after the intervention/procedure/surgery

Conditions

PARKINSON DISEASE (Disorder)

NCT07215403

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Medical University of South Carolina
Charleston, South Carolinastudy coordinator listed
The Ohio State University Wexner Medical Center Neurological Surgery
Columbus, Ohiostudy coordinator listed
University Hospitals Cleveland Medical Center
Cleveland, Ohiostudy coordinator listed
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvaniastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

AskFirst Patient Engagement

[email protected]

919-561-6210

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

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

What this trial measures

Amount of the putamen covered by the drug at the end of infusion, assessed by MRIimmediately after the intervention/procedure/surgery
Investigate the use of PIA-based infusion for consistent intraputaminal administration of AB-1005 via CED under iMRI monitoring

Trialytics