Funded Studies
Study Rationale: Like the brain, the retina is part of the central nervous system. We therefore aim to develop a new and simple way to diagnose Parkinson’s disease (PD) via examination of the eye. To do this, we have created a method to detect a defining feature of PD, the buildup of alpha-synuclein inside neurons. Our test uses a “retinal tracer” that emits fluorescent when it binds to alpha-synuclein in neurons within the retina, generating a signal that can be detected with devices already in use by ophthalmologists when they perform eye exams.
Hypothesis: We propose that our retinal tracer will bind to aggregates of alpha-synuclein in the retina and emit a fluorescent light signal that can be detected by ocular imaging devices to help diagnose PD.
Study Design: We will perform a clinical trial in people with PD and healthy volunteers in which our retinal tracer will be tested to evaluate its safety, tolerability, time-course in the retina and body and its ability to fluorescently label buildups of alpha-synuclein in the retina. We will administer increasing doses of our retinal tracer in a stepwise fashion in different groups of individuals with PD, while carefully monitoring its safety and activity at each step.
Impact on Diagnosis/Treatment of Parkinson’s Disease: Our method for detecting alpha-synuclein in the retina will be easy to use, safe and affordable —which will help doctors accurately diagnose individuals with PD more rapidly and treat them at earlier stages of disease. It will also accelerate the development of new therapeutics for PD.
Next Steps for Development: Based on the results of our clinical trial, Amydis plans to pursue a subsequent larger clinical trial in people with PD and healthy volunteers that would support an application to the Food and Drug Administration (FDA) for approval and marketing of our novel PD diagnostic test.
Trial Phase: Phase 1/2a