Translation of bergamot essential oil in clinical trial for control of behavioural and psychological symptoms of dementia
The essential oil of bergamot (BEO; Citrus bergamia Risso et Poiteau) is endowed with analgesic activity in inflammatory and neuropathic pain models. Modulation of endogenous peripheral and central opioid system and morphine dose rescue are among the main pharmacological activities of the phytocomplex. Due to the tight link between undertreated pain and agitation in patients suffering from severe dementia, aromatherapy can turn out to be a useful approach if an essential oil with powerful analgesic activity is used. Methodological limitations of most aromatherapy trials hamper any conclusion about its effectiveness in dementia. Based on the strong preclinically proven antinociceptive and anti-allodynic activity of BEO, a nanotechnology-based delivery system consisting of odorless alpha-tocoferyl stearate solid lipid nanoparticles loaded with BEO deprived of furocoumarins (NanoBEO; patent EP 4003294), has been engineered and tested, confirming the previously demonstrated efficacy of the phytocomplex. Thus, the actually active BRAINAID (NCT04321889) double-blind, randomized, placebo-controlled, clinical trial has been designed to assess the effectiveness of NanoBEO on agitation and pain in severely demented patients to offer a safe tool able to provide relief to this fragile population.
BEO is the first essential oil to be deviced in a nanotechonology delivery system (NanoBEO) to allow double-blind, randomized, clinical trial (NCT04321889) for the control of agitation in patients with severe dementia.