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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07566429

Enrollment

Registered

2026-05-05

Start date

2027-01-25

Completion date

2032-12-15

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Gene therapy

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).

Interventions

DRUGAB-1005

Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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: 1. Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability 2. Presence of motor fluctuations as measured by the PD Motor Diary 3. Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening 4. Responsiveness to levodopa therapy

Exclusion criteria

* 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: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure * Chronic immunosuppressive therapy

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse events up to Month 18 after study intervention	Up to 18 months	Number and proportion of participants with at least one adverse event
Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary	Up to 18 months	—

Countries

Japan

Contacts

CONTACTBayer Clinical Trials Contact

clinical-trials-contact@bayer.com18888422937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026