In a recent study published in Frontiers in Medicine, researchers showed that "almost 90% of patients with dementia suffer from some type of neurobehavioral symptom, and there are no approved medications to address these symptoms."
Neuropsychiatric symptoms (NPS) occur in up to 90% of patients with dementia and are associated with a reduced quality of life, according to the study and is
characterized by a progressive decline in "cognitive and functional abilities and challenging behavioral symptoms, is one of the major causes of disability and dependency among older adults.”
The clinical trial aims to evaluate the "safety and efficacy of the medical cannabis oil “Avidekel” for the reduction of behavioral disturbances among patients with dementia."
"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," reads the clinical trial.
Moreover, researchers noted that "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."
According to the researchers, the treatment "was mostly safe, with no significant differences in the occurrence of adverse events between the two groups."
Of 60 randomized patients: with an average age of 79.4 years; "36 women (60.0%)], 52 (86.7%)" completed the trial. According to the researchers, just eight patients, from the investigational group, discontinued treatment.
Finally, researchers said that their findings “suggest that rich-CBD cannabis oil may alleviate agitation in older patients with dementia.” “One trial is not enough to make conclusions on the safety and efficacy of broad-spectrum CBD,” they added.
“We recommend conducting a large-scale randomized controlled trial on behavioral disturbances related to dementia and comparing clinical sub-types of dementia,” researchers concluded.
Materials & Methods:
The randomized, double-blind, single-cite, placebo-controlled trial was conducted in a tertiary hospital in Israel from December 2017 to September 2019, on 60 years or older patients.
"With a diagnosis of the 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) or a placebo oil three times a day for 16 weeks."
During the 16-week treatment period, participants came in for follow-up every two weeks, with the option to terminate their participation. In addition, after completing the study, all trial participants were offered the option to renew their cannabis treatment license.
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