Open-Label, Multi-Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)
AskBio Inc
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 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
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)…
Eligibility
- Age range
- 45–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- ProcedurePrescriptive Infusion Algorithm
The study intervention is comprised of the neurosurgical procedure and the bilateral intraputaminal delivery of AB-1005.
- DrugAB-1005
bilateral intraputaminal delivery of AB-1005
Location
- The Ohio State University Wexner Medical Center Neurological SurgeryColumbus, Ohio