Dementia
Study register · detail RCT (placebo-kontrolliert) · Dementia · 2022

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

Clear benefit GRADE Moderate 24 citations
Samplen = 60 Pat.
Duration16 weeks
ControlPlacebo oil, three times daily orally over…
EndpointCMAI
Blindingdoppelblind
DesignRCT (placebo-kontrolliert)
Cannabinoidvollspektrum
THC:CBD1:30
Routeoral
Key finding

Avidekel oil reduced agitation significantly more than placebo: 60% vs. 30% achieved a ≥4-point reduction in the Cohen-Mansfield Agitation Inventory Score (p=0.03), with good safety.

Summary

RCT (n=60, mean age 79,4 years, 60% women) on CBD-rich oil (30% CBD/1% THC) vs. placebo for behavioral disturbances in dementia over 16 weeks. Primary endpoint (CMAI reduction ≥4 points): 60,0% (24/40) under active treatment vs. 30,0% (6/20) under placebo (χ²=4,80, p=0,03). CMAI reduction ≥8 points: 50% vs. 15% (χ²=6,42, p=0,011). ANOVA showed significantly greater improvement at week 14 and 16 (F=3,18, p=0,02). Good tolerability, no significant differences in adverse events.

P
PopulationPatients with dementia and behavioral disturbances, age ≥60 years, n=60 randomized (n=40 intervention, n=20 control group)
I
Intervention'Avidekel' broad-spectrum cannabis oil (30% CBD, 1% THC; 295 mg/ml CBD, 12,5 mg/ml THC), three times daily orally over 16 weeks
C
ControlPlacebo oil, three times daily orally over 16 weeks
O
OutcomeProportion with CMAI score reduction ≥4 points at week 16: 60% (intervention group) vs. 30% (control), p=0,03; reduction ≥8 points: 50% vs. 15%, p=0,011; ANOVA: significantly more improvement at weeks 14 and 16 (F=3,18, p=0,02)
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding Double-blind
Effect size Clear benefit
Citations / year
Authors
Hermush V, Ore L, Stern N et al.
DOI 10.3389/fmed.2022.951889
Design: RCT (placebo-kontrolliert)
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