Medical cannabis dementia trial study protocol determined
MELBOURNE: The medical cannabis dementia trial study protocols have been finally determined and published today.
The University of Notre Dame Australia’s Institute for Health Research (IHR) and MGC Pharma have announced publication of the study protocol for a clinical trial evaluating medical cannabis use with patients with dementia.
The trial was registered in the Australian and New Zealand Clinical Trial Register (ANZCTR) earlier this week. The research project, will delve into the effects of medicinal cannabis oil among those living in a residential aged care facility medically diagnosed with dementia.
The trial involves an N-of-1, randomised double blind trial cross-over approach with those participating receiving either an oil-based placebo or medical cannabis oil containing THC and CBD. The trial aims to monitor the effects of administering the oil and to determine if there are any changes in behaviour, quality of life, discomfort or pain levels or weight.
The primary question the study is seeking to answer is:
Does medicinal cannabis affect the behavioural symptoms of care recipients with dementia?
Secondary research questions include:
- Does medicinal cannabis affect care recipients with dementia quality of life?
- Does medicinal cannabis affect care recipients with dementia discomfort and pain?
“We’re hoping to see a lot of changes in behaviour,” says Dr Amanda Timler, “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.”
As well as providing the product being tested (CogniCann) and assisting with other aspects of the trial, MGC Pharma are providing access to medical experts in Israel with extensive experience in using medical cannabis with both cancer patients and children with epilepsy. This will help ensure the Western Australian trial follows a safe process.
