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PARKINSON DISEASE (Disorder)Phase 2PIANCT07215403

Prescriptive Infusion Algorithm (PIA)

A Phase 2 study testing Prescriptive Infusion Algorithm and AB-1005 in people with PARKINSON DISEASE (Disorder), run by AskBio Inc at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
PARKINSON DISEASE (Disorder)
What is being tested?
Prescriptive Infusion Algorithm and AB-1005
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesUnited States
Study dates
Nov 2026to 1 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AskFirst Patient Engagement contact

919-561-6210

askfirst@askbio.com

United States4 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Sandra Wilson, wilsosan@musc.edu

    (843)-792-4616

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Stacy Pot, 216-844-5605, stacy.pot@uhhospitals.org

    Camilla Kilbane, MD

  • The Ohio State University Wexner Medical Center Neurological Surgery

    Columbus, Ohio, 43210

    Andrea Davis, 614-814-6871, andrea.davis@osumc.edu

    Brad Elder, MD

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Sherry Mosovsky, MPH, 412-692-4659, mosovskysl@upmc.edu

    Valerie Suski, MD

Other trials in United States

About this study

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

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.

Read more

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

Read the detailed description

Participants will receive a one-time infusion of AB-1005 directly into the putamen on each side of the brain. This is done during a surgical procedure under general anesthesia. The drug is delivered using a special technique called convection-enhanced delivery (CED), which helps spread the drug evenly in the target brain tissue. 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).

The study has three main stages, the initial group of 6 participants and the other 2 stages with two small groups (sub-stages) of 3 participants. Each group will receive the same treatment, and results will be reviewed before moving to the next group.

All participants will receive AB-1005. The study is open-label, meaning both participants and doctors know what treatment is given.

After the follow-up period, all participants will continue into a long-term follow-up (LTFU) study. In the LTFU study, participants' health will be monitored for up to 10 years after their surgery.

Being tested
Prescriptive Infusion Algorithm, AB-1005
Keywords
PD, Parkinsons Disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prescriptive Infusion AlgorithmProcedure or surgery

    The study intervention is comprised of the neurosurgical procedure and the bilateral intraputaminal delivery of AB-1005.

  • AB-1005Drug

    bilateral intraputaminal delivery of AB-1005

Study groups in NCT07215403
Study groupRoleWhat they receive
Stage 1ExperimentalStage 1 is aimed at evaluating the suitability of PIA-based infusion for standardized intraputaminal administration of AB-1005 via CED under iMRI monitoring.
Receives: Procedure: Prescriptive Infusion Algorithm; Drug: AB-1005

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Investigate the use of PIA-based infusion for consistent intraputaminal administration of AB-1005 via CED under iMRI monitoring

    Measured: immediately after the intervention/procedure/surgery

Secondary outcomes (3)

  1. Duration of surgical procedure

    Reduce the time the surgical procedure is performed

    Measured: through study completion, an average of 1 year

  2. Change in total volumetric putaminal coverage within approximately 60-120 min from end of infusion

    Measured: immediately after the intervention/procedure/surgery

  3. Accuracy of cannula tip placement at targeted first and last infusion stops in putamen

    Measured: immediately after the intervention/procedure/surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2025
  2. Study startNov 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215403
Sponsor's protocol ID
ASK-PD5-CS202
Acronym
PIA
Status last verified
Jul 2026
First submitted
26 Sep 2025
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prescriptive Infusion Algorithm and AB-1005 in people with PARKINSON DISEASE (Disorder), run by AskBio Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AskFirst Patient Engagement (919-561-6210, askfirst@askbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of the putamen covered by the drug at the end of infusion, assessed by MRI (time frame: immediately after the intervention/procedure/surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07215403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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