Parkinson's Disease Clinical Trial
Official title:
An Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Into the Putamen of Subjects With Parkinson's Disease With Fluctuating Responses to Levodopa
Safety study of AADC gene transfer (VY-AADC01) in subjects with Parkinson's disease.
Parkinson's disease is a neurodegenerative disorder involving loss of neurons that release
dopamine in the striatum. To compensate for the loss of dopamine, patients are typically
prescribed levodopa medication which is converted to dopamine by the enzyme Aromatic L-Amino
Acid Decarboxylase (AADC). As Parkinson's disease progresses, levodopa therapy becomes less
effective and is associated with motor fluctuations, involuntary movements and other
complications.
This study will primarily investigate the safety of increasing AADC levels in the striatum
via AADC gene delivery. The hAADC gene is packaged into a gene transfer vector derived from a
common, non-pathogenic virus (AAV2) to which >90% of humans have been exposed. This
investigational drug, termed VY-AADC01, will be injected directly into the striatum during a
neurosurgical procedure that is performed with real-time MRI imaging to monitor delivery.
Subjects will continue to take Parkinson's disease medications, including levodopa.
The safety and potential clinical responses to VY-AADC01 will be assessed by repeated
clinical evaluations of Parkinson's disease, cognitive tests, laboratory blood tests and
neuroimaging. Clinical evaluations will be performed over a 3 year follow-up period. A test
to specifically assess the clinical response to levodopa will be performed once before AADC
gene delivery and approximately 6 months after.
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