Dementia is one of the most common causes of disability worldwide characterized by
memory loss,
cognitive impairment, and behavioral and psychological symptoms (BPSD), including agitation. Treatment of the latter consists of the
off-label use of harmful atypical
antipsychotics, though a significant reduction is afforded by
pain control. The use of an
essential oil endowed with
analgesic properties and devoid of toxicity would represent an important option for the management of agitation in dementia. Therefore, the aim of this study was to engineer a nanotechnology delivery system based on solid
lipid nanoparticles loaded with bergamot
essential oil (BEO) and devised in the pharmaceutical form of an odorless cream (NanoBEO) to confirm its
analgesic efficacy for further development and application to control agitation in dementia. BEO has proven strong antinociceptive and anti-allodynic properties and, in its
bergapten-free form, it is completely devoid of
phototoxicity. NanoBEO has been studied in vivo confirming the previously reported
analgesic activity of BEO to which is now added its anti-
itching properties. Due to the nanotechnology delivery system, the stability of titrated BEO components is guaranteed. Finally, the latter invention, currently under patent consideration, is smell-devoid allowing efficacy and safety to be established in double-blind clinical trials; until now the latter studies have been impeded in
aromatherapy by the strong odor of
essential oils. A clinical trial NCT04321889 has been designed to provide information about the efficacy and safety of NanoBEO on agitation and
pain in patients suffering from severe
dementia.