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Study of BIA 28-6156 in Parkinson's Disease (PD) risk-associated varient in the GBA1 gene (ACTIVATE)

Research Question:
Does the drug, BIA 28-6156, delay progression of the disease in people with Parkinson's Disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene?

Basic Study Information

This is a 2-part (Part A [Genetic Screening] and Part B [Double-Blind Treatment]) study to test if 2 fixed dose levels of BIA 28-6156 (10 and 60 mg/day) delays progression of Parkinson's Disease in approximately 237 subjects with genetically confirmed GBA-PD. Part A (Genetic Screening) will identify individuals with a PD risk-associated variant in the GBA1 gene for potential enrolment into Part B (Double-Blind Treatment) of the study. Part B will consist of a screening period to ensure that all protocol inclusion/exclusion criteria for Part B of the study are met. After the screening period, eligible subjects will be randomized into 1 of 3 treatment arms (BIA 28-6156 10 mg/day, BIA 28-6156 60 mg/day, or placebo) in a 1:1:1 ratio Subjects must be receiving a stable dose of PD medication for at least 30 days before screening (for Part B [Double-Blind Treatment]) and will continue to receive their usual PD medications throughout the study. You may be eligible if you have the variant of the GBA gene, are 35-80 years old, have a diagnosis of PD for 1-7 years and are receiving treatment for PD.

Location: 919 Westfall Rd., Building C, Suite 100, Rochester, NY 14618
Study Reference #: STUDY00008460

Lead Researcher (Principal Investigator)

Lead Researcher:  Ruth Schneider

Study Contact Information

Study Coordinator: Hannah Mesmer
Phone: (585) 341-7577

Additional Study Details

Parking:  Free
Reimbursement:  Yes

Learn More About These Conditions

More information about Parkinson Disease

More information about Parkinson's disease

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