Prescriptive Infusion Algorithm (PIA)

Part of paid clinical trials in Columbus, Ohio.

Sponsor
AskBio Inc
Study ID
NCT07215403
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Prescriptive Infusion Algorithm — PROCEDURE
    The study intervention is comprised of the neurosurgical procedure and the bilateral intraputaminal delivery of AB-1005.
  • AB-1005 — DRUG
    bilateral intraputaminal delivery of AB-1005

Study Details

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

Key Dates

Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center Neurological SurgeryColumbusOhio43210
Andrea Davis
[email protected]
614-814-6871

Find similar trials in Columbus, OH

By research site
The Ohio State University Wexner Medical Center Neurological Surgery· Columbus, OH

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