7 December 2020
Researchers at NICM Health Research Institute are set to examine the effects of a complex cannabis-based medicine on cognitive function in people with early-stage Alzheimer’s disease, the most common cause of dementia.
The project, a collaboration between NICM Health Research Institute and Australian Natural Therapeutics Group (ANTG), will recruit over the next two years 80 volunteers, for the 12-week randomised, double-blind, placebo-controlled Phase II trial.
Project Chief Investigator and Director of Research at NICM Health Research Institute, Associate Professor Genevieve Steiner says the research has the potential to lead to a desperately needed medical breakthrough for Alzheimer’s disease in an area that has seen over 150 failed attempts at developing drugs for this indication over the past 20 years.
“Mild cognitive impairment is a transitional stage between healthy cognitive ageing and dementia. When memory problems are present it significantly increases the risk of Alzheimer’s disease,” said Associate Professor Steiner.
“There are currently no approved treatments for mild cognitive impairment, and anti-Alzheimer’s disease medications have not been shown to improve memory and thinking in mild cognitive impairment over time, nor do they address the underlying causes of the disease.
“We’re really excited to be partnering with ANTG to advance research in Alzheimer’s disease using a complex cannabis-based treatment in what will be a world-first clinical trial in humans.
“Cannabis rich in cannabidiol (CBD) has been shown to offer properties such as neuroprotection, neurogenesis and anti-inflammatory effects which are relevant to the underlying pathology of Alzheimer’s disease, and medium chain triglycerides (MCTs) can help improve neuronal (brain cell) survival and metabolism. Both have demonstrated promising results on cognition in previous research studies.”
The trial will use ANTG’s Eve strain, which is a CBD rich whole plant extract that also contains other cannabinoids and terpenes including delta-9-tetrahydrocannabinol (THC), in addition to MCTs for the compound combination.
The research team are currently finalising the protocols for ethics approval and final trial registration, aiming to start screening people in 2021 to see if they are eligible to take part in the study.
Supplementing the clinical trial, Co-Chief Investigator, Professor Tim Karl, School of Medicine, will also test the therapeutic potential and superiority systematically in an established preclinical research model relevant to dementia.
Both studies are funded by Western Sydney University and ANTG.