MGC Pharmaceuticals Ltd (‘MGC Pharma’ or ‘the Company’), a European based bio-pharma company specialising in the production and development of phytomedicines, is pleased to provide details of the results of its Phase II Clinical Trial into the effect of its proprietary Investigational Medicinal Product, CogniCann, an oral spray containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), on patients with Dementia.
The double-blind cross-over Clinical Trial was undertaken in conjunction with the University of Notre Dame in Western Australia and involved eligible patients commencing a six-week treatment course with CogniCann, before switching (crossing over) to a six-week course of placebo, with a two-week ‘washout’ period between the two arms. The study’s objectives were to assess the safety and efficacy of CogniCann, including the assessment of the behavioural benefits of CogniCann on Dementia patients measured using a number of evaluation tools including a Neuropsychiatric Inventory – Nursing homes (NPI-NH) Questionnaire and a Cohen-Mansfield Agitation inventory Questionnaire.
A summary of the study’s protocol can be found in Annexure A of this Announcement.
The study assessed the safety profile of CogniCann by monitoring adverse events and a range of observational tests undertaken by a research nurse who met with each participant to discuss their adverse event records, and measured their heart rate and blood pressure twice a week. In addition, the participant’s weight and body composition measures, such as lean body mass, bone mass and fat mass were measured weekly utilising non-invasive methods. The study assessed both the safety profile and the efficacy of CogniCann against a placebo, with the study results demonstrating no difference in the safety profile between the CogniCann and Placebo groups i.e. indicating that CogniCann was safe to use by patients with Dementia.
The efficacy of CogniCann was assessed using the following three criteria:
1. The participant’s NPI-NH Score using the Neuropsychiatric Inventory – Nursing Home Version (NPI-NH) Questionnaire, which is based on responses from the participants, and from caregivers involved in their daily care.
The NPI-NH Questionnaire was developed to help characterise the neuropsychiatric symptoms and psychopathology of patients with Alzheimer’s disease and other dementia patients residing in nursing homes or extended care facilities. The NPI-NH is also used to measure the impact of anti-dementia drugs on these patients.
Results of the study 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, indicating that the early-stage use of CogniCann may be beneficial in the treatment of dementia patients.
2. Aggressive behaviour
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. During the 44-day study period the treatment group’s Cohen-Mansfield Agitation Inventory Aggressive subscale improved by 13%, compared with the Placebo group which improved by 4%. This important finding 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 graph below demonstrates the change in the aggressive behaviour between the Treatment and Placebo groups. Both groups started from similar Aggression evaluation scale values, with the Treatment group (green columns) showing increased improvement compared to the Placebo, or Control group (red columns). These results can be considered as a vector and will be studied in future clinical trials using a larger sample size.
3. Cohen-Mansfield Agitation Inventory (CMAI)3
The CMAI is a 29-item scale widely used to assess the frequency of manifestations of agitated behaviours in elderly persons, which is completed by a proxy (i.e. family carer or nursing home staff members). The study demonstrated that the Treatment group’s CMAI score improved by ~17%, from 69 to 57, compared with the Placebo group’s improvement of ~8% over the 44-day period. Agitation is a behavioural syndrome characterised by increased, often undirected, motor activity, restlessness, aggressiveness, and emotional distress. According to several observations, agitation prevalence ranges from 30 to 50% in dementia patients.
The Clinical Trial, which commenced in March 2020, initially planned to enrol 50 patients from a number of Aged Care Facilities across Perth, Western Australia, however, as a result of the COVID-19 pandemic, and the resulting restrictions place on accessing Aged Care Facilities by Australian government agencies, the time taken to complete the trial was longer than anticipated, resulting in the number of patients enrolled in the trial being reduced from the initial target of 50 to 22.
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.