Early Motor Parkinson’s DAT Clinical Trial Enrichment Tool
This quantitative clinical trial enrichment tool helps optimize clinical trial design in the early-motor stages of Parkinson’s, using MDS-UPDRS part III as the primary endpoint.
Early Motor Parkinson’s DAT Clinical Trial Enrichment Tool GUI
CPP and QuantMed would like to acknowledge the leadership and contributions from the following team members:
- Daniela Conrado (Alnylam)
- Kenneth Marek (Institute for Neurodegenerative Disorders)
- Vikram Sinah (Merck)
- Jesse Cedarbaum (Coeruleus Clinical Sciences)
About the Early Motor PD Clinical Trial Enrichment Tool
For scientists and clinicians of all backgrounds, a cloud-based graphical user interface (GUI) has been developed, which allows a user-friendly experience to perform simulations based on the model.
To access the tool files, please click on the “Apply for R scripts.” For any additional questions related to the tool, please email admodelinfo@c-path.org.
A quantitative clinical trial enrichment tool to help optimize clinical trial design in the early-motor stages of Parkinson’s disease, using MDS-UPDRS part III as the primary endpoint.
A disease progression model, which integrates baseline dopamine transport imaging, the effect of patient drop-out and relevant sources of variability.
Replacement for well conducted trials with real patients
A thorough description of the clinical trial simulation tool can be found here.
- Sample size calculations for specific trial design parameters
- Trial-specific enrichment or stratification approaches using baseline molecular dopamine imaging determination of optimal trial durations and frequency of assessments for assumed drug effects.
- Exploratory impact of digital measures that may capture equivalent motor features to those captured by the MDS-UPDRS part III, but with reduced variability
