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A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease
Sponsor: Bayer
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).
Official title: A Phase 2, Open-label, Single Group, Fixed-dose Study to Evaluate the Safety and Efficacy of a Single Bilateral Intraputaminal Administration of AB-1005 (AAV2-GDNF Gene Therapy) in Japanese Participants With Moderate Stage Parkinson's Disease
Key Details
Gender
All
Age Range
45 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2026-07-27
Completion Date
2032-06-15
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
AB-1005
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Locations (6)
Nagoya Central Hospital - Neurosurgery
Nagoya, Aichi-ken, Japan
Nagoya University Hospital - Neurology
Nagoya, Aichi-ken, Japan
Yokohama City University Medical Center - Neurology
Yokohama, Kanagawa, Japan
Juntendo University Hospital - Neurology
Bunkyo-ku, Tokyo, Japan
National Hospital Organization Utano National Hospital - Neurology
Kyoto, Japan
National Hospital Organization Osaka Toneyama Medical Center - Neurology
Osaka, Japan