After two years of hard work and multiple hurdles to overcome, The University of Notre Dame Australia's Institute for Health Research (IHR) and MGC Pharma have hit a new milestone with publication of the study protocol for the clinical trial on the value of medical cannabis for patients with dementia.
This trial has been registered in the Australian and New Zealand Clinical Trial Register and, following rigorous review by external experts of the study's design and planned analytical methods, its protocol has just been published in the prestigious journal, Trial. The study is currently the only one in Australia into the potential benefits of medical cannabis in Dementia patients.
Recruitment into the study has been challenging as the Western Australian Guardianship and Administration Act (1990), unlike in the case of medical treatment, does not enable next of kin to authorise participation of people in a clinical trial. Despite enormous interest in the study from the community, this has limited the number of people eligible to enrol, as participants must only have a mild form of dementia in order to give their own consent to be involved.
Just getting the medication to Australia to use in the study has added another level of complexity. The medication is manufactured and packaged in Europe and then exported to Australia and comes in the form of a precise mix of cannabis components at a highly specific dose.
"We've had to be very clear that we're not just giving dementia patients a joint to smoke," Dr Amanda Timler says,
It's an oral spray that administers a certain dosage of purified medicinal cannabinoid medication. We were waiting for it to arrive in Australia for a long time, but it's now here, which is a big step forward.
A unique relationship with the industry partner MGC Pharma has allowed for a valuable synchronicity between production and research. Often with research projects of this type, the research represents theoretical usage of the end product, whereas MGC Pharma will be likely to move the treatment forward and get it to the market if the results are positive.
"MGC Pharma have also provided us with access to medical experts in Israel who have extensive experience in using medical cannabis with both cancer patients and children with epilepsy to ensure the Western Australian study follows a safe process," Professor Codde says.
While the study is only just beginning, Amanda has been considering what the results may mean for those suffering from dementia. Current treatment for neurological symptoms associated with dementia can include antidepressants and antipsychotics, mostly to manage the symptoms of the disease, however, these treatments can be ineffective, harsh on the already vulnerable bodies of patients, and can even lead to an increased rate of mortality.
"We're hoping to see a lot of changes in behaviour," Amanda says, "reductions in the symptoms associated with dementia such as depression, anxiety, lack of empathy, poor sleep quality, drastic changes in appetite, and an overall general improvement in quality of life.
"At this stage we're using the spray as a supplement in addition to currently prescribed medications, just to see if there is an effect overall," Amanda says, "but in the long term, we'd like to see a reduction in the use of other medications. We're hoping to do a follow up study after this to see if there's any chance of replacing current medication. We've had an amazing number of calls from the community seeking to find something that could help their loved ones, and we are hoping this may help to find a solution, but we are making sure that we move forward methodically so we do not to create any unnecessary harm or build expectations of an effect that may not exist.
"It's very early days at the moment, but it's exciting to be part of this project unfolding and working closely with the aged care providers helping us recruit participants."
