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Starting soon Phase 2

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

NCT07566429 · tracked via the Priya Life Science Japan tracker
Sponsor
Phase
Phase 2
Started
2027-01-25
Last updated
2026-07-29

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

AB-1005 →

AB-1005: Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose

Study 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).

Eligibility

Sex
ALL
Min age
45 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (6)

FacilityCityRegionStatus
Nagoya Central Hospital - Neurosurgery Nagoya Aichi-ken
Nagoya University Hospital - Neurology Nagoya Aichi-ken
Yokohama City University Medical Center - Neurology Yokohama Kanagawa
National Hospital Organization Osaka Toneyama Medical Center - Neurology Toyonaka Osaka
Juntendo University Hospital - Neurology Bunkyo-ku Tokyo
National Hospital Organization Utano National Hospital - Neurology Kyoto Japan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07566429 on ClinicalTrials.gov ↗ ← All trials in Japan