Study register · detailRCT · Geriatric Patients · 2023
Examining the use of cannabidiol and delta-9-tetrahydrocannabinol-based medicine among individuals diagnosed with dementia living within residential aged care facilities: Results of a double-blind randomised crossover trial.
Timler et al.·Australasian journal on ageingImpact 1.3
MixedGRADEModerate7 citations
Samplen = 21 Pat.
Duration18 weeks
ControlPlacebo
EndpointNPI
Blindingdoppelblind
DesignRCT
Cannabinoidkombination
THC:CBD3:2
Routeoral
”Key finding
No significant differences between placebo and cannabinoid medicine for behaviour, quality of life or pain, except for a decrease in agitation at the end of treatment in favour of the cannabinoid medicine.
Summary
n=21 dementia patients in nursing homes (77% female, mean age 85 years), 18-week RCT THC:CBD 3:2 vs. placebo; no significant differences in BPSD, QoL or pain except for a reduction in agitation at end of treatment in favour of CBM. Qualitative data: improved relaxation/sleep in some individuals. Post-hoc estimate: n=50 required for NPI sensitivity. Minimal side effects, medication appeared safe.
P
PopulationOlder adults with dementia in residential aged care facilities (RACF), n=21, mean age 85 years, 77% female
I
InterventionTHC:CBD-based medicine (3:2 ratio delta-9-THC:CBD), oral administration, titrated to tolerable dose, 18-week crossover period
C
ControlPlacebo
O
OutcomeNo significant differences between CBM and placebo for behaviour, quality of life or pain; significant reduction in agitation at end of treatment in favour of CBM
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeMixed
Citations / year★★★★★
Authors
Timler A, Bulsara C, Bulsara M, Vickery A, Jacques A, Codde J
Objective: Dementia affects individuals older than 65 years. Currently, residential aged care facilities (RACF) use psychotropic medications to manage behavioural and neuropsychiatric symptoms of dementia (BPSD), which are recommended for short-term use and have substantial side effects, including increased mortality. Cannabinoid-based medicines (CBM) have some benefits that inhibit BPSD and cause minimal adverse effects (AEs), yet limited research has been considered with this population. The study aimed to determine a tolerable CBM dose (3:2 delta-9-tetrahydrocannabinol:cannabidiol), and assessed its effect on BPSD, quality of life (QoL) and perceived pain.
Methods: An 18-week randomised, double-blinded, crossover trial was conducted. Four surveys, collected on seven occasions, were used to measure changes in BPSD, QoL and pain. Qualitative data helped to understand attitudes towards CBM. General linear mixed models were used in the analysis, and the qualitative data were synthesised.
Results: Twenty-one participants (77% female participants, mean age 85) took part in the trial. No significant differences were seen between the placebo and CBM for behaviour, QOL or pain, except a decrease in agitation at the end of treatment in favour of CBM. The qualitative findings suggested improved relaxation and sleep among some individuals. Post hoc estimates on the data collected suggested that 50 cases would draw stronger conclusions on the Neuropsychiatric Inventory.
Conclusions: The study design was robust, rigorous and informed by RACF. The medication appeared safe, with minimal AEs experienced with CBM. Further studies incorporating larger samples when considering CBM would allow researchers to investigate the sensitivity of detecting BPSD changes within the complexity of the disease and concomitant with medications.