Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT07215403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prescriptive Infusion Algorithm (PIA)
Sponsor:
AskBio Inc
Organization:
Study Overview
Official Title:
Open-Label, Multi-Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 two main stages, each 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.
The study has two main stages, each 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: