a medical cannabis oil for treatment of agitation and disruptive behaviors in subjects with dementia.

Conditions: Agitation,Psychomotor; Disruptive Behavior; Dementia; Alzheimer Disease

Summary: this double-blind, placebo-controlled study is designed to assess the effectiveness of, medicane's medical cannabis oil extracted from medicane's proprietary strain into gmp-grade olive oil, as an add-on therapy to standard of care (soc), in reducing agitation and disruptive behaviors in subjects with dementia including probable ad.


Eligibility criteria:
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.