Study Rationale: Parkinson’s disease (PD) is linked to abnormal clumps of a protein in the body called alpha-synuclein (asyn), which can now be detected in living people using an advanced laboratory test. At present, this test requires a lumbar puncture to collect spinal fluid, which is an invasive procedure unsuitable for repeated screening. Research shows asyn changes appear in the gut years before movement symptoms begin, suggesting that intestinal samples could enable earlier, easier detection. This study will test CapScan, a swallowable capsule that collects intestinal fluid, to see if it can detect asyn and reveal gut-related biological changes linked to PD, thereby offering a potential non-invasive alternative for early PD diagnosis and staging.
Hypothesis:We hope to demonstrate that CapScan collects intestinal fluids containing asyn in people with PD and that measurements of asyn in these samples match well with the measurements of asyn made in their spinal fluid.
Study Design: This pilot study will include 20 people with PD and 20 healthy volunteers of similar age. Each person will swallow a CapScan device and we will first check how safe and comfortable the capsule is to use when studying this disease. Next, we will measure the amount of asyn in the intestinal fluid and compare the results to those from a standard spinal fluid test. We will also measure the gut bacteria, molecules, and proteins in the intestinal fluid to look for other biological changes linked to PD.
Impact on Diagnosis/Treatment of Parkinson’s disease: CapScan could offer a simple, swallowable way to detect early signs of PD, improving diagnosis, tracking, and treatment development.
Next Steps for Development: If successful, the next steps towards clinical application would involve validating the study results in a study with more participants.