Agitation Related to Dementia Clinical Trial
Official title:
A Phase II, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Avidekel Oil for the Treatment of Subjects With Agitation Related to Dementia
The most common syndrome in patients with severe dementia is agitated behavior, which is often characterized by a combination of violent behavior (physical or verbal), restlessness, and inappropriate loudness. The treatment options for this syndrome are limited and lead to severe side effects. In vivo experiments on animals and clinical studies on adults show that cannabinoids could have a beneficial effect on behavioral disorders in general, and in dementia-related disorders in particular. Additionally, medical cannabis patients have reported that cannabis aids in pain relief, increased appetite, and a sense of calm and peace of mind. Elderly patients suffering from dementia that experience this syndrome could also benefit from other quality of life aspects of the cannabis treatment such as reduction in medication consumption, weight gain and improvement of sleep.
In this randomized, double-blind placebo-controlled trial, 60 patients will be randomly assigned to receive either CBD-A (30:1) cannabis rich low THC oil (30% CBD and 1% THC) or a placebo oil. The primary efficacy endpoint was a decrease of four or more points on the Cohen-Mansfield Agitation Inventory (CMAI) score by week 16, as compared to baseline. Secondary endpoints included improvement of other neurobehavioral symptoms. The following questionnaires will be administered by trained staff at every visit: The CMAI, a to measure the types and frequencies of agitated behaviors, and the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) to measure behavioral disturbances. ;