Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's Disease

Exclusion Criteria

• •Atypical or secondary parkinsonism, including but not limited to symptoms believed to be due to trauma, brain tumor, infection, cerebrovascular disease, other neurological disease, or to drugs, chemicals, or toxins.
• •Presence of dementia as defined by a Mattis Dementia Rating Scale - Second Edition (MDRS-2) score of less than 130 at screening.
• •Presence or history of psychosis, with the exception of mild, benign hallucinations believed in the judgment of the Investigator to be related to Parkinson's medications.
• •Presence of severe depression, as indicated by a BDI-II score greater than 28, or a history of a major affective disorder within 5 years of screening evaluation.
• •Active suicidal ideation or suicide attempt within 5 years of screening evaluation.
• •History of substance abuse within 2 years of screening evaluation.
• •Brain imaging abnormalities in the striatum or other regions that would substantially increase risk of surgery.
• •Contraindication to MRI and/or gadoteridol.
• •Coagulopathy or inability to temporarily stop any anticoagulation or antiplatelet therapy prior to surgery.
• •Prior brain surgery including lesioning procedures, deep brain stimulation, infusion therapies or any other brain surgery.
• •Prior gene transfer.
• •History of stroke, poorly controlled or significant cardiovascular disease, diabetes, or any other acute or chronic medical condition.
• •History of malignancy other than treated carcinoma in situ within 3 years of screening evaluation.
• •Clinically apparent or laboratory-detected infection.
• •Prior or current treatment with any investigational agent within 2 months of screening evaluation.
• •Inability to comply with the procedures of the protocol, including completion of paper Parkinson's disease diaries, frequent and prolonged study visits including off medication visits, and travel.
• •Chronic immunosuppressive therapy, including chronic steroids, immunotherapy, cytotoxic therapy, and chemotherapy.
• •Any serious medical condition or abnormal finding on physical examination or laboratory investigation that would substantially increase the risks of the study procedures.
• •Any medical condition that is likely to lead to disability during the course of the study and interfere with or confound study assessments.
• •Pregnant and lactating women.
• •Male or female with reproductive capacity who is unwilling to use barrier contraception for 6 months after surgery.
• •Plans to receive any vaccination within 30 days of surgery.
• •Any factors, medical or social, which would likely cause the participant to be unable to follow the study protocol, including geographical inaccessibility.
• •Ongoing treatments including neuroleptic medications, apomorphine, or levodopa infusion therapy (Duopa®).
• •Plans to participate in any other therapeutic intervention study within 12 months after surgery.