AUTHOR=Hermush Vered , Ore Liora , Stern Noa , Mizrahi Nisim , Fried Malki , Krivoshey Marina , Staghon Ella , Lederman Violeta E. , Bar-Lev Schleider Lihi 

TITLE=Effects of rich cannabidiol oil on behavioral disturbances in patients with dementia: A placebo controlled randomized clinical trial

JOURNAL=Frontiers in Medicine

VOLUME=9

YEAR=2022

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.951889

DOI=10.3389/fmed.2022.951889

ISSN=2296-858X

ABSTRACT=<sec><title>Background</title><p>Almost 90% of patients with dementia suffer from some type of neurobehavioral symptom, and there are no approved medications to address these symptoms.</p></sec><sec><title>Objective</title><p>To evaluate the safety and efficacy of the medical cannabis oil “Avidekel” for the reduction of behavioral disturbances among patients with dementia.</p></sec><sec><title>Materials and methods</title><p>In this randomized, double-blind, single-cite, placebo-controlled trial conducted in Israel (<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link>: NCT03328676), patients aged at least 60, with a diagnosis of major neurocognitive disorder and associated behavioral disturbances were randomized 2:1 to receive either “Avidekel,” a broad-spectrum cannabis oil (30% cannabidiol and 1% tetrahydrocannabinol: 295 mg and 12.5 mg per ml, respectively; <italic>n</italic> = 40) or a placebo oil (<italic>n</italic> = 20) three times a day for 16 weeks. The primary outcome was a decrease, as compared to baseline, of four or more points on the Cohen-Mansfield Agitation Inventory score by week 16.</p></sec><sec><title>Results</title><p>From 60 randomized patients [mean age, 79.4 years; 36 women (60.0%)], 52 (86.7%) completed the trial (all eight patients who discontinued treatment were from the investigational group). There was a statistically significant difference in the proportion of subjects who had a Cohen-Mansfield Agitation Inventory score reduction of ≥ 4 points at week 16: 24/40 (60.0%) and 6/20 (30.0%) for investigational and control groups, respectively (χ<sup>2</sup> = 4.80, <italic>P</italic> = 0.03). There was a statistically significant difference in the proportion of subjects who had a Cohen-Mansfield Agitation Inventory score reduction of ≥ 8 points at week 16: 20/40 (50%) and 3/20 (15%), respectively (χ<sup>2</sup> = 6.42, <italic>P</italic> = 0.011). The ANOVA repeated measures analysis demonstrated significantly more improvement in the investigational group compared to the control group at weeks 14 and 16 (<italic>F</italic> = 3.18, <italic>P</italic> = 0.02). Treatment was mostly safe, with no significant differences in the occurrence of adverse events between the two groups.</p></sec><sec><title>Conclusion</title><p>In this randomized controlled trial, ‘Avidekel’ oil significantly reduced agitation over placebo in patients suffering from behavioral disturbances related to dementia, with non-serious side-effects. Further research is required with a larger sample size.</p></sec>