A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)
Condition(s) studied
Investigational drug(s) / intervention(s)
AB-1005: Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Study summary
The objective of this Phase 2, open-label, single group, one-time, fixed-dose study is to assess the safety and efficacy of bilateral intraputaminal infusion of AB-1005 (AAV2-GDNF gene therapy) in Japanese patients with moderate Parkinson's Disease (PD).
Eligibility
Primary outcome measure(s)
- Incidence of adverse events up to Month 18 after study intervention — Up to 18 months
Number and proportion of participants with at least one adverse event - Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary — Up to 18 months
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Nagoya Central Hospital - Neurosurgery | Nagoya | Aichi-ken | |
| Nagoya University Hospital - Neurology | Nagoya | Aichi-ken | |
| Yokohama City University Medical Center - Neurology | Yokohama | Kanagawa | |
| National Hospital Organization Osaka Toneyama Medical Center - Neurology | Toyonaka | Osaka | |
| Juntendo University Hospital - Neurology | Bunkyo-ku | Tokyo | |
| National Hospital Organization Utano National Hospital - Neurology | Kyoto | Japan |
More Bayer trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07566429 on ClinicalTrials.gov ↗ ← All trials in Japan