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
Purpose:
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
Email: hannah_mesmer@urmc.rochester.edu
Additional Study Details
Parking:
Free
Reimbursement:
Yes
Learn More About These Conditions
More information about Parkinson Disease
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