MedPharm, a Colorado-based cannabis research and formulation development company, has received a Medical Marijuana Research and Development License from the City of Denver, the last piece in the licensing puzzle for the company’s study on how cannabis-based medication might impact Alzheimer’s disease and other forms of dementia.
MedPharm received a state research license over a year ago, according to the company’s Director of Chemistry Dr. Tyrell Towle, and the local permit now allows the company to launch its research, which will initially be a small study with 30 participants.
MedPharm is working with a local neurologist to recruit dementia patients for the study.
“He’s already introduced the idea to many of them and he’s gotten a positive response,” Towle said. “We’ll be recruiting from his current patient population and, if necessary, we’ll [seek] more patients, more volunteers.”
MedPharm will administer gel capsules that contain both cannabinoids and other natural, non-cannabis-derived compounds that have been shown to have a positive effect on brain health. The company will also distribute a cannabinoid-only formulation, as well as a placebo, to compare how each formulation performs.
“What we’re hoping to see is [that] the cannabinoid-only formulation improves symptoms and blood flow … better than the placebo, and then we’re hoping that the full formulation improves the outcomes of the patients even better than the cannabinoid-only formulation,” Towle said. “That would be the ideal outcome of the study, but we’ll just have to see what happens.”
Over the course of the six-month study, which will launch once all the patients are enrolled within the next month or so, MedPharm will monitor whether the patients’ symptoms are improving—whether they’re sleeping better, eating better or feeling less agitated, for example. The company will conduct regular caregiver surveys to evaluate these symptoms, and it will also use brain scans to monitor blood flow.
“From that, we’re hoping to see increased blood flow to the areas of the brain that are important to Alzheimer’s and dementia, and also see what else is going on,” Towle said. “Maybe there’s increased blood flow in an area of the brain we didn’t anticipate, and we can look at future medical benefits of targeting that.”
MedPharm will also take blood samples and measure them for inflammatory biomarkers that are associated with brain damage.
Once the initial study is complete, the company will determine which form of dementia is best treated with medical cannabis, as well as which dosage form works best. Then, MedPharm hopes to expand the clinical trial to a large enough population to provide statistical significance.
“Ultimately, we hope to get an FDA-approved medication that helps to either slow down the progression of Alzheimer’s disease or at least improve the symptoms,” Towle said. “At the very least, we want to relieve symptoms, but if we can also slow down the progression or prevent the development of the disease, that would be ideal.”
MedPharm has applied with the DEA to obtain a federal license to cultivate cannabis for research, and although the company was notified last year that its application has been selected to advance in the application process, it has yet to receive another update.
“It’s a slow-go,” Towle said. “[The DEA is] on their own time schedule, that’s for sure.”
Published at Wed, 24 Jun 2020 14:56:00 +0000