NCT07566429Not yet recruitingPhase 2
A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)
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
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 28 Apr 2026
- Start date
- 25 Jan 2027
- Primary completion date
- 15 Jun 2029
- Lead sponsor
- Bayer
- Diseases
- Parkinson disease
- NCT number
- NCT07566429
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 8
- From 25 Jan 2027 to the primary completion date, 15 Jun 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
- Chronic immunosuppressive therapy
Other illness
- 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
Other
- Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
Who the study is looking for
- 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
Age in the registry: 45 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Juntendo University Hospital - Neurology Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| National Hospital Organization Utano National Hospital - Neurology Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Nagoya Central Hospital - Neurosurgery Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Nagoya University Hospital - Neurology Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| National Hospital Organization Osaka Toneyama Medical Center - Neurology Coordinator of this site? Confirm its status | Toyonaka | Japan | Unknown status |
| Yokohama City University Medical Center - Neurology Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.