Perth-based cannabis trial forges ahead

In the long-reaching shadow of COVID-19, research at The University of Notre Dame Australia continues unabated. Notre Dame’s Institute for Health Research (IHR) and MGC Pharma are ramping up recruitment efforts and pushing ahead with the deployment of medical cannabis for eligible patients with dementia.

Last year we reported that researchers and project partners had hit a new milestone in the publication of the study protocol for the clinical trial. Of course, this was before the full effects of the pandemic were known, but despite the many issues around borders, importing medical supplies, lockdowns, and the obstacles of getting into aged care facilities to reach patients, Dr Amanda Timler and her team have been working hard to ensure this important research can continue.

“COVID did cause some issues,” Dr Timler says, “But this is true for all research projects across the board.

“There has been a six month to a year gap where we have been waiting for lockdown restrictions to be lifted within aged care facility, but during this time we have been able to stay engaged with the interested facilities and refine our research processes.”

Through positive relationships with aged care providers and further good news in the form of changes to the Western Australian Guardianship and Administration Act (1990), the research itself never stopped, and has in fact broadened in opportunity.

“We’re really in a good place where we can actually include those with moderate to severe dementia, “Dr Timler says, “So we’ve been able to expand the scope of our study to be able to include those who we think will benefit the most from the medication.”

Whereas researchers were initially unable to gain next of kin consent for those experiencing moderate to severe dementia, this change to the Act means next of kin are now able to authorise participation of family members for a clinical trial, which has effectively opened the door for a far wider range of participants to become eligible.

“We screened seven participants before Christmas who can now taking part in the trial, but they wouldn’t have even been eligible before the change in the Act.”

Still recruiting, Dr Timler says the initial strict criteria around eligibility of participants had caused some issues, especially when it came to those who seemed to be eligible before deteriorating further and entering the moderate to severe stage of their condition, thereby nullifying their eligibility.

“We were going to facilities and they were saying ‘we have 60 residents’, from which we could initially see perhaps 20 being eligible. But then when you start looking into their histories, their case files and through the inclusion requirements, suddenly it’s whittled down to just two individuals.”

It’s been challenging, and obstacles have been thrown in her path, but Dr Timler remains optimistic about the study, keen for the work to result in positive outcomes for those suffering from dementia and the families and friends who have to endure the pain of watching their loved ones with this condition.

“I want this project to succeed,” Dr Timler says, “I’ve been very persistent with it. We’re in a good space now to keep going and I’m happy to be busy. I’m happy to have sleepless nights because I can see movement and progress and things finally starting to happen on the ground again.”

Institute for Health Researcher Director Professor Jim Codde said the project is “not without its challenges,” but added that “the potential good for people suffering from dementia drives us on. As the COVID-19 period has shown, we need good science to help shine a light on the best way forward.”

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