A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.
- EligibilityCriteria: 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 defined by the following:  Presence of bradykinesia PLUS any of the following:  Rigidity Rest Tremor Postural instability  Modified Hoehn and Yahr stage II-III in the practically defined OFF medication state (>/= 12 hours from last dose of anti-parkinsonian medications) MDS-UPDRS Part III score in the practically defined OFF state of 33 to 60 (inclusive) Presence of motor fluctuations with >/= 2.5 hours of absolute time in the OFF state averaged over 3 days as measured by the PD Motor Diary, and assessed at screening, and baseline visit 1 and 2 Stable anti-parkinsonian medication regimen for >/= 4 weeks prior to Screening and held stable throughout the baseline period o Responsiveness to levodopa as determined by change in modified H&Y stage or MDS-UPDRS Part III score from the practically defined OFF state to ON state after taking first daily dose of PD medication  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 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 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 - HealthyVolunteers: No - Gender: All - MinimumAge: 45 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult