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

Abstract

BackgroundAlmost 90% of patients with dementia suffer from some type of neurobehavioral symptom, and there are no approved medications to address these symptoms.ObjectiveTo evaluate the safety and efficacy of the medical cannabis oil “Avidekel” for the reduction of behavioral disturbances among patients with dementia.Materials and methodsIn this randomized, double-blind, single-cite, placebo-controlled trial conducted in Israel (ClinicalTrials.gov: 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; n = 40) or a placebo oil (n = 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.ResultsFrom 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 (χ2 = 4.80, P = 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 (χ2 = 6.42, P = 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 (F = 3.18, P = 0.02). Treatment was mostly safe, with no significant differences in the occurrence of adverse events between the two groups.ConclusionIn 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.

The Main Therapeutic Applications of Cannabidiol (CBD) and Its Potential Effects on Aging with Respect to Alzheimer’s Disease

“…There was also a significant difference in the number of patients achieving a decrease of at least eight points, i.e., 50% versus 15% of patients (p = 0.01). Treatment was very well tolerated by patients with similar adverse event profiles in both arms of the study [97]. Also, another smaller study (n = 20) mentions a therapeutic benefit of 3% CBD in the treatment of severe behavioral and psychological symptoms of dementia [98], and further studies are planned [99].…”

Cannabinoids for Behavioral Symptoms in Dementia: An Overview

“…The three others 12 13 14 showed no positive impact after 3, 6, or 12 weeks, but the THC treatment was well tolerated. In one RCT 15 , 40 patients treated with CBD/THC oil (30:1) for 16 weeks showed significant clinical improvement.…”

“…Four trials were double-blinded 12 13 14 15 and assessed differences between treatments and/or placebo. One trial 11 aimed to determine the monitoring method to evaluate treatment activity; therefore, the study subjects and personnel were not blinded.…”