Gene therapy trial for moderate Parkinson's disease in Japanese adults
Tests one-time brain infusion of AB-1005 gene therapy in people with Parkinson's.
Plain-language title generated from the registry record
Registry title: A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)
Key facts
- Where
- Bunkyo-ku, Kyoto, Nagoya, Toyonaka, and Yokohama, JapanSee the 6 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 75 years old?
Source: NCT07566429, who can take part
Where in Japan
- Juntendo University Hospital - NeurologyBunkyo-ku, JapanNo longer taking part
- National Hospital Organization Utano National Hospital - NeurologyKyoto, JapanNo longer taking part
- Nagoya Central Hospital - NeurosurgeryNagoya, JapanNo longer taking part
- Nagoya University Hospital - NeurologyNagoya, JapanNo longer taking part
- National Hospital Organization Osaka Toneyama Medical Center - NeurologyToyonaka, JapanNo longer taking part
- Yokohama City University Medical Center - NeurologyYokohama, JapanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bayer
- Trial code
- NCT07566429
- Record updated
- 29 July 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent; Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) and currently meeting all the following criteria:; Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability; Presence of motor fluctuations as measured by the PD Motor Diary; Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening; Responsiveness to levodopa therapy.
Exclusion: Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure; Chronic immunosuppressive therapy; Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis; Presence or history of significant vascular and/or cardiovascular disease; Presence of clinically significant cognitive impairment; Presence or history of psychosis or impulse control disorder; History of malignancy other than treated cutaneous squamous or basal cell carcinomas; Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety; Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents.