Effects of rich cannabidiol oil on behavioral disturbances in patients with dementia: A placebo controlled randomized clinical trial.
agitation
behavioral disturbances
cannabidiol
dementia
medical cannabis
neuropsychiatric symptoms
randomized controlled trial (RCT)
Journal
Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047
Informations de publication
Date de publication:
2022
2022
Historique:
received:
24
05
2022
accepted:
15
08
2022
entrez:
23
9
2022
pubmed:
24
9
2022
medline:
24
9
2022
Statut:
epublish
Résumé
Almost 90% of patients with dementia suffer from some type of neurobehavioral symptom, and there are no approved medications to address these symptoms. To evaluate the safety and efficacy of the medical cannabis oil "Avidekel" for the reduction of behavioral disturbances among patients with dementia. 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; 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 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.
Sections du résumé
Background
UNASSIGNED
Almost 90% of patients with dementia suffer from some type of neurobehavioral symptom, and there are no approved medications to address these symptoms.
Objective
UNASSIGNED
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
UNASSIGNED
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;
Results
UNASSIGNED
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
Conclusion
UNASSIGNED
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.
Identifiants
pubmed: 36148467
doi: 10.3389/fmed.2022.951889
pmc: PMC9486160
doi:
Banques de données
ClinicalTrials.gov
['NCT03328676']
Types de publication
Journal Article
Langues
eng
Pagination
951889Informations de copyright
Copyright © 2022 Hermush, Ore, Stern, Mizrahi, Fried, Krivoshey, Staghon, Lederman and Bar-Lev Schleider.
Déclaration de conflit d'intérêts
LB-L and VL report employment at Tikun-Olam Cannbit Pharmaceuticals Ltd., with stock options in the company. LB-L reports consulting role with TO Pharmaceuticals LLC. As a consultant of the company, LB-L was registered as an inventor on a patent on the investigational product for behavioral disturbance in patients with dementia. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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