A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.

Inclusion Criteria: * Subjects are Male or Female age ≥50 years. * Subjects have a diagnosis of major neurocognitive disorder (previously dementia) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria for at least 6 months prior to screening or a diagnosis of probable AD using the NINCDS-ADRDA clinical criteria. * Subjects on antipsychotic medications may be included in the study. * Subject exhibits agitation/aggression with a Neuropsychiatric Inventory (NPI-12)-agitation/aggression subdomain score of four or higher (≥4) at screening. * Subject has a legal guardian who is able and willing to provide ICF and able to provide - information in writing. The caregiver should be spending enough time with the subject on a regular basis in order to provide valid information as requested. * Subjects are on stable SoC for treatment of agitation and disruptive behaviors for at least 2 weeks prior to the screening visit. * Subjects on Acetyl Choline Esterase inhibitors, antifungals, macrolide antibiotics and anti-hypertensive therapy including ACE inhibitors should be on stable doses for at least 2 weeks prior to screening visit or if changed, at least 2 weeks prior to visit 1. * Subject's Mini Mental State Exam score (MMSE) is 24 or less at screening. Exclusion Criteria: * Subject without a legal guardian. * Subject with any current unstable medical condition. * Subject has any unstable condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, or cardiac symptoms or disease. * Subject has one of the following hepatic /renal disorders: 1. Confirmed and unexplained impaired hepatic function as indicated by screening AST or ALT\>3 the upper limit of normal (ULN) or total bilirubin \> 2 ULN. 2. Chronic kidney disease of Stage \> 4, according to National Kidney Foundation Kidney Disease Outcome Quality Initiative guidelines for chronic kidney disease. * Subject has epilepsy. * Subject has a history of hypersensitivity to any cannabinoid. * Subject has the presence or history of a primary psychotic psychiatric disorder or subject has clinically significant delusions or hallucinations secondary to the neurodegenerative disease (NPI-12 delusions or hallucinations sub-score of 4 or higher (≥4). * Subject suffering from delirium as defined in Appendix B - Criteria for Delirium. * Current inpatient hospitalization. * Subject has other health-related factors that could explain behavioral disturbances (electrolyte disturbances, infectious diseases, etc.). * Subject has a satisfactory response to antipsychotic treatments. * Subjects treated with one of the following medications: opiates, primidone, phenobarbitol, carbamazepine, rifampicin, rifabutin, troglitazone, hypericum perforatum, or valproic acid within 30 days from Visit 1. * Subjects currently on medication known to interact with Cannabis-based medications are excluded; Subjects taking Cannabis-based therapies are excluded if within the past 2 weeks from Visit 1. * Subjects with a history of addiction or drug abuse.