MGC Pharmaceuticals’ phase II clinical trial of its CogniCann THC/CBD oral spray has shown the drug can inhibit behaviour deterioration in dementia patients and is safe to use.
In the study, undertaken in conjunction with the University of Notre Dame in Western Australia, 22 patients commenced a six-week course with CogniCann before switching to six weeks on a placebo, with a two-week ‘washout’ period between the two.
Based on responses from participants and their caregivers, those in the placebo group experienced a deterioration in their condition after 44 days while those treated with CogniCann were stable.
Aggressive behaviour, measured using the Cohen-Mansfield Agitation Inventory, improved by 13% in the treatment group compared to 4% in the placebo group, while agitated behaviour also improved.
The company said the findings indicate early-stage use of CogniCann may be beneficial in treating dementia patients.
It added: “This important finding indicates not only improvement in the health status of the patients, but also improved quality of life of the families and caregivers that are taking care of [them].”
The results will be used in the design of the next phase of clinical trials for CogniCann, including defining the appropriate end points and patient sample size.