A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease
J-REGENERATE-P
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
2 other identifiers
interventional
8
1 country
6
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 parkinson-disease
Started Jul 2026
Longer than P75 for phase_2 parkinson-disease
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2026
CompletedFirst Posted
Study publicly available on registry
May 5, 2026
CompletedStudy Start
First participant enrolled
July 27, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2028
Study Completion
Last participant's last visit for all outcomes
June 15, 2032
May 5, 2026
April 10, 2026
2.4 years
April 28, 2026
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events up to Month 18 after study intervention
Number and proportion of participants with at least one adverse event
Up to 18 months
Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary
Up to 18 months
Study Arms (1)
AB-1005 infusion
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Prior history of brain surgery including, but no limited: deep brain stimulation, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
- Chronic immunosuppressive therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- AskBio Inccollaborator
Study Sites (6)
Nagoya Central Hospital - Neurosurgery
Nagoya, Aichi-ken, 453-0801, Japan
Nagoya University Hospital - Neurology
Nagoya, Aichi-ken, 466-8560, Japan
Yokohama City University Medical Center - Neurology
Yokohama, Kanagawa, 232-0024, Japan
Juntendo University Hospital - Neurology
Bunkyo-ku, Tokyo, 113-8431, Japan
National Hospital Organization Utano National Hospital - Neurology
Kyoto, 616-8255, Japan
National Hospital Organization Osaka Toneyama Medical Center - Neurology
Osaka, 560-8552, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2026
First Posted
May 5, 2026
Study Start (Estimated)
July 27, 2026
Primary Completion (Estimated)
December 15, 2028
Study Completion (Estimated)
June 15, 2032
Last Updated
May 5, 2026
Record last verified: 2026-04-10
Data Sharing
- IPD Sharing
- Will not share
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.