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Prescriptive Infusion Algorithm (PIA)

NCT07215403 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-10-10

No results posted yet for this study

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)

Interventions

PROCEDURE

Prescriptive Infusion Algorithm

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

DRUG

AB-1005

bilateral intraputaminal delivery of AB-1005

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • AskBio Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-30
Completion
2028-03-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215403 on ClinicalTrials.gov