Open-Label, Multi Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)

Condition studied

Parkinson's Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence and severity of AEs including: serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), TEAEs related to device and/or surgical procedure, TEAEs related to study drug

Endpoint detail

Absolute values and changes from baseline in: MoCA score, BDI-II score, C-SSRS , vital sign parameters, physical examinations, clinical laboratory measures, and neuroimaging findings, Immunological responses to AAV2 and/or GDNF, End-of-infusion volumetric coverage of the putamen as assessed by MRI, Duration of surgical procedure, Accuracy of cannula tip placement at targeted first and last infusion points in the putamen