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NCT Number: NCT07566429

A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)

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).

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya Central Hospital - Neurosurgery, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

AB-1005

Drug

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

Primary outcomes

  1. Incidence of adverse events up to Month 18 after study intervention

    Time frame: Up to 18 months

    Number and proportion of participants with at least one adverse event

  2. Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary

    Time frame: Up to 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

18888422937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • AskBio Inc

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
May 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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