Study Rationale:
Parkinson’s disease results in functional and structural changes in the brain. Non-invasive imaging methods such as SPECT and MRI can measure these changes. The dopamine transporter (DaT) is a biological target measured using DaTSCAN SPECT imaging. Changes in the volume of certain brain structures, such as basal ganglia nuclei and substantia nigra, are measured using structural MRI. SPECT and MRI images are analyzed to produce quantitative biomarkers that are tracked over time to monitor disease progression. The variability in these endpoints, however, leads to clinical trials requiring a large number of patients which necessitates costly trials in large patient populations.
Hypothesis:
Improved analytical approaches for DaT and MRI imaging could provide endpoints with increased accuracy and lower variability. This would lead to a significant reduction in costs and recruitment required for Parkinson's clinical trials without modification to current imaging trial infrastructure.
Study Design:
Invicro believes it can achieve substantial improvements for Parkinson's clinical trials by developing and applying DATIQ as an improved analysis algorithm for DaT imaging data and by applying deep learning super-resolution MRI pre-processing to structural MRI. The DaTSCAN work will extend the IQ-Analytics platform developed by Invicro (which has demonstrated improvements in performance for biomarker analysis of amyloid and tau imaging data in Alzheimer’s disease) to DaT imaging in Parkinson's. The MRI work will utilize Invicro’s custom 3-D deep learning super-resolution pipeline to improve the resolution of small anatomical structures in brain images. These tools will be applied to clinical data in the Parkinson's Progression Markers Initiative to assess their performance on real world data and compare it to currently applied methods.
Impact on Diagnosis/Treatment of Parkinson’s Disease:>
Improved methods for analyzing DaTSCAN and structural MRI data would lead to smaller, more cost-effective clinical trials of new therapies for Parkinson's.
Next Steps for Development:
If successful, these imaging biomarker analyses would be deployed to ongoing and future trials of potential Parkinson's therapeutics.