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NOT YET RECRUITING
NCT07566429
PHASE2

A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease

Sponsor: Bayer

View on ClinicalTrials.gov

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

Interventions

DRUG

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