Placebo-controlled study – Dementlief for behavioral disorders in Dementia patients

Frontiers in Medicine 2022

Vered Hermush1,2, Liora Ore3, Noa Stern1,2, Nisim Mizrahi1, Malki Fried1, Marina Krivoshey1, Ella Staghon1, Violeta E Lederman4, Lihi Bar-Lev Schleider4,5

1Geriatric Wing, Laniado Hospital, Netanya, Israel; 2Technion School of Medicine, Haifa, Israel; 3Department of Graduate Studies in Health Systems Management, The Max Stern Yezre’el Valley College, Israel; 4Research Department, Tikun-Olam Cannbit Pharmaceuticals, Israel; 5Clinical Research Center, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Be’er-Sheva, Israel

The most common and consistent symptom in patients with severe dementia is a disorder that is often characterized by a combination of aggression (verbal and/or physical), restlessness and inappropriate language.

The treatment options for this symptom are limited and with severe side effects. The usual treatment is antipsychotics which have been defined in this sensitive population as increasing the risk of mortality. Animal studies and clinical trials in adults suggest that cannabinoids may have a mitigating effect on behavioral disorders in general and behavioral disorders associated with dementia in particular. In addition, the analgesic and calming effect, and the increased appetite reported by patients consuming medical cannabis, can also benefit the elderly who suffer from dementia in other aspects of quality of life such as medication, weight and sleep.

The aim of this randomized, double-blind, placebo-controlled study conducted in collaboration with Laniado Hospital was to examine the effect of Dementlief oil, 30% CBD and 1% THC, on dementia patients with behavioral disorders. The efficacy was tested with a valid and trusted questionnaire – CMAI (Cohen-Mansfield Agitation Inventory), where a significant improvement is defined as an improvement of four points or more, thus this was the therapeutic target. The study found that cannabis use is safe and effective among dementia patients with behavioral problems and can significantly reduce (13.3 points improvement) negative behavioral symptoms, with few side effects.

STUDY POPULATION: 60 patients with dementia (36 females, mean age 79).

STUDY PRODUCT: Dementlief oil with 30% CBD and 1% THC VS placebo (33% of patients received placebo).

RESULTS:

• 8 patients (13.3%) discontinued treatment during the 16 weeks of follow-up.

Decrease in agitation and aggression – 68.7% of the participants in the cannabis group showed a significant reduction in agitation and aggression, compared to only 30.0% in the placebo group (on average, the treatment group improved by 13.3 points in the CMAI sore while the placebo group improved by only 2.5 points).

 44% of the participants in the cannabis group showed a significant reduction in agitation and aggression, compared to only 5% in the placebo group.

Decrease in behavioral disorders – A significant decrease in behavioral disorders was found in the cannabis group compared to the placebo group.

Decrease in sleep disturbances – 37.5% of patients in the cannabis group reported that they no longer suffer from sleep disorders (compared with 15.0% in the placebo group).

• Side effects – No significant differences were observed between the cannabis group and the placebo group.

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