Prescriptive Infusion Algorithm (PIA)

NCT07215403 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ASK-PD5-CS202
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

PARKINSON DISEASE (Disorder)

Keywords

PD; Parkinsons Disease

Outcome Measures

Primary Outcomes (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

  immediately after the intervention/procedure/surgery

Secondary Outcomes (3)

• Duration of surgical procedure

  through study completion, an average of 1 year

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

  immediately after the intervention/procedure/surgery

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

  immediately after the intervention/procedure/surgery

Study Arms (1)

Stage 1

EXPERIMENTAL

Stage 1 is aimed at evaluating the suitability of PIA-based infusion for standardized intraputaminal administration of AB-1005 via CED under iMRI monitoring.

Procedure: Prescriptive Infusion Algorithm; Drug: AB-1005

Interventions

Prescriptive Infusion Algorithm PROCEDURE

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

Stage 1

AB-1005 DRUG

bilateral intraputaminal delivery of AB-1005

Stage 1

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AskBio Inc: lead
• Bayer: collaborator

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 10, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share