MGC Pharma has announced results from its clinical trial, stating that CogniCann has demonstrated the ability to inhibit the deterioration in the behaviour of patients with Dementia.
The European based bio-pharma company, MGC Pharma carried out the trial in conjunction with the University of Notre Dame in Western Australia.
CogniCann’s specific ratio of THC to CBD is designed to improve behaviour and cognition in dementia patients. MGC Pharma recently signed a supply and distribution agreement with Sciensus Rare for the distribution of CogniCann in a number of European countries.
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Its Phase II trial assessed both the safety profile and the efficacy of CogniCann against a placebo, and involved 22 participants taking a six-week treatment course with CogniCann, before switching to a six-week course of placebo, with a two-week ‘washout’ period between the two arms.
MGC Pharma has stated that the study results demonstrate no difference in the safety profile between the CogniCann and Placebo groups, indicating that the formula was safe to use by patients with Dementia.
The results showed that after 44 days, patients in the placebo group experienced a deterioration in their condition, based on their NPI-NH score, compared with the stable neuropsychiatric profile of those patients treated with CogniCann. MGC Pharma has said that this indicates early-stage use of CogniCann may be beneficial in the treatment of dementia patients.
Aggressive behaviour is one of the most serious of the disturbances experienced by dementia patients, and is a common cause for psychiatric referral, admission to hospital and drug treatment. MGC Pharma has stated that the trial results showed that, during the 44-day study period, the treatment group’s Cohen-Mansfield Agitation Inventory Aggressive subscale improved by 13 per cent, compared with the placebo group which improved by 4 per cent.
The company says this finding is important as it indicates not only improvement in the health status of the patients, but also the improved quality of life of the families and caregivers that are taking care of dementia patients.
The CMAI is a 29-item scale widely used to assess the frequency of manifestations of agitated behaviours in elderly persons. The study demonstrated that the treatment group’s CMAI score improved by ~17 per cent, from 69 to 57, compared with the placebo group’s improvement of ~8 per cent over the 44-day period.
Results from the study 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.
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