A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria: Confirmed Parkinson's Disease Levodopa responsiveness for at least 12 months UPDRS Part 3 score of ≥25 points in the "off" state Exclusion Criteria: Past history of brain surgery to treat Parkinson's Disease Any history of cerebral insult or central nervous system infection Atypical Parkinson's Disease Focal or lateralized neurologic deficits Evidence of significant medical or psychiatric disorders Cognitive impairment as defined by Montreal Cognitive Assessment (MoCA)≤20 Beck Depression Inventory-II score of ≥ 20
Sites / Locations
- Yale University - Yale New Haven Hospital
- Henry Ford West Bloomfield HospitalRecruiting
- Weill Cornell MedicineRecruiting
- Columbia University Irving Medical CenterRecruiting
- Thomas Jefferson UniversityRecruiting
- West Virginia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Sham Comparator
AAV-GAD Dose 1 treatment group
AAV-GAD Dose 2 treatment group
Sham treatment group
Eligible participants will receive bilateral infusion of AAV-GAD Dose 1 into the STN
Eligible participants will receive bilateral infusion of AAV-GAD Dose 2 into the STN
Eligible participants will undergo a sham surgical procedure