Dataset Information

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

ABSTRACT:

Background

Almost 90% of patients with dementia suffer from some type of neurobehavioral symptom, and there are no approved medications to address these symptoms.

Objective

To evaluate the safety and efficacy of the medical cannabis oil "Avidekel" for the reduction of behavioral disturbances among patients with dementia.

Materials and methods

In 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.

Results

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 (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.

Conclusion

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.

SUBMITTER: Hermush V

PROVIDER: S-EPMC9486160 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

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

Hermush Vered V Ore Liora L Stern Noa N Mizrahi Nisim N Fried Malki M Krivoshey Marina M Staghon Ella E Lederman Violeta E VE Bar-Lev Schleider Lihi L

Frontiers in medicine 20220906

<h4>Background</h4>Almost 90% of patients with dementia suffer from some type of neurobehavioral symptom, and there are no approved medications to address these symptoms.<h4>Objective</h4>To evaluate the safety and efficacy of the medical cannabis oil "Avidekel" for the reduction of behavioral disturbances among patients with dementia.<h4>Materials and methods</h4>In this randomized, double-blind, single-cite, placebo-controlled trial conducted in Israel (ClinicalTrials.gov: NCT03328676), patien ...[more]

PMID: 36148467

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Dataset Information

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

Background

Objective

Materials and methods

Results

Conclusion

Publications

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

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