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).

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