Brain imaging and data analytics company CereHealth Corporation has scored approval to conduct a Sun Pharma Advanced Research Company (SPARC) sponsored study that will utilize SPECT imaging to investigate the use of K0706 as a treatment for patients with early Parkinson’s disease.
The Phase II study was secured through CereScan, a subsidiary of CereHealth Corp and a national network of functional brain imaging and analytics centers. The network’s Littleton, Colorado site will be the location of the study and utilize DaT SPECT to perform scans of participants’ brains.
"Sponsors and CROs are utilizing more tools in their arsenal to determine the efficacy and safety of therapeutics under development," John Kelley, chairman and CEO of CereHealth Corp., told HCB News. "DaTscan is a type of functional brain imaging that shows visual evidence of a Parkinsonian syndrome in the brain, and is an accepted measurement procedure for pre- and post-evaluation."
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Close to one million individuals are expected to be living with Parkinson’s disease in the U.S. by 2020, according to the Parkinson’s Foundation. The figure outweighs the combined number of people diagnosed with multiple sclerosis, muscular dystrophy and Lou Gehrig’s disease. Direct and indirect costs are estimated by this time to reach nearly $52 billion per year.
DaT SPECT depicts the density of healthy dopamine neurons and will be used in the interventional trial to help researchers evaluate the efficacy and safety of ABL tyrosine kinase inhibition using K0706.
The study will be randomized, double-blinded, and placebo-controlled, with an estimated 504 diagnosed participants enrolled. Each will be diagnosed with "Clinically Probable PD" and display a documented onset of symptoms within three years of the screening.
CereScan will act as the SPECT imaging center for Denver Neurological Research, the approved independent, private clinical research site where Phase I through Phase IV trials take place.
"Similar to Denver Neurological Research, CereScan in an independent research and imaging site with expertise in functional brain imaging. DNR trusts that we will provide a concierge-like experience and conducive environment for patients struggling with complex neurological disorders," said Kelley. "Based on our prior imaging work, DNR trusts our strict adherence to the industry's safety standards and patient's well-being, and delivery of the highest quality imaging and analytics in the region."
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