A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)

Prior treatment

• Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
• Chronic immunosuppressive therapy

Other illness

• 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 significant cognitive impairment, poorly controlled depression/anxiety
• 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

Other

• Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents

• Age
• Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
• Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
  • 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 prior to screening
  • Must demonstrate responsiveness to levodopa therapy