NCT04321889: BEO

Efficacy of Defurocumarinized Bergamot in the Treatment of Agitation in Severe Dementia Patients.

Status unknown NA Last updated 25 March 2020

What this trial tests

NA trial testing defurocumarinized bergamot loaded in a nanotechnological essential oil release system in Severe Dementia in 134 participants. Status unknown.

Timeline

1 April 2020

Primary endpoint
10 December 2020

30 June 2021

Quick facts

Lead sponsor	S.Anna Rehabilitation Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	134
Start date	1 April 2020
Primary completion	10 December 2020
Estimated completion	30 June 2021

Drugs / interventions tested

• defurocumarinized bergamot loaded in a nanotechnological essential oil release system
• Placebo

Conditions studied

• Severe Dementia — all drugs for Severe Dementia →
• Stroke — all drugs for Stroke →

Sponsor

S.Anna Rehabilitation Institute

Who can join

Adults 65 to 80, any sex, with Severe Dementia or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the efficacy of defurocumarinized bergamot in the treatment of agitation in severe dementia patients. Bergamot essential oil (BEO), able to modulate the endogenous, peripheral and central opioid system involved in painful states, has developed in models of inflammatory pain and neuropathic pain; it is also effective when administered by inhalation.

Participants in the study will be divided into 2 parallel groups, one treatment group and one placebo, to evaluate the clinical efficacy of defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream in the treatment of agitation, in in Over-sixty-five-year-old patients of both sexes diagnosed with severe dementia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pattern of treatment of behavioural and psychological symptoms of dementia and pain: evidence on pharmacoutilization from a large real-world sample and from a centre for cognitive disturbances and dementia.
   Scuteri D, Vulnera M, Piro B, Bossio RB, et al · · 2021 · cited 34× · PMID 32935181 · DOI 10.1007/s00228-020-02995-w
2. Development and Translation of NanoBEO, a Nanotechnology-Based Delivery System of Bergamot Essential Oil Deprived of Furocumarins, in the Control of Agitation in Severe Dementia.
   Scuteri D, Cassano R, Trombino S, Russo R, et al · · 2021 · cited 28× · PMID 33809385 · DOI 10.3390/pharmaceutics13030379
3. Bergamot rehabilitation AgaINst agitation in dementia (BRAINAID): Study protocol for a randomized, double-blind, placebo-controlled trial to assess the efficacy of furocoumarin-free bergamot loaded in a nanotechnology-based delivery system of the essential oil in the treatment of
   Scuteri D, Sandrini G, Tamburin S, Corasaniti MT, et al · · 2021 · cited 22× · PMID 34435395 · DOI 10.1002/ptr.7223
4. Preclinical Characterization of Antinociceptive Effect of Bergamot Essential Oil and of Its Fractions for Rational Translation in Complementary Therapy.
   Scuteri D, Rombolà L, Crudo M, Watanabe C, et al · · 2022 · cited 19× · PMID 35214045 · DOI 10.3390/pharmaceutics14020312
5. Translational Value of the Transdermal Administration of Bergamot Essential Oil and of Its Fractions.
   Scuteri D, Rombolà L, Crudo M, Watanabe C, et al · · 2022 · cited 11× · PMID 35631592 · DOI 10.3390/pharmaceutics14051006
6. Aromatherapy in Stroke Patients: Is it Time to Begin?
   Contrada M, Cerasa A, Tonin P, Bagetta G, et al · · 2021 · cited 8× · PMID 34955776 · DOI 10.3389/fnbeh.2021.749353
7. Dementia and COVID-19: A Case Report and Literature Review on Pain Management.
   Scuteri D, Contrada M, Tonin P, Corasaniti MT, et al · · 2022 · cited 7× · PMID 35215311 · DOI 10.3390/ph15020199
8. Analgesic Characteristics of NanoBEO Released by an Airless Dispenser for the Control of Agitation in Severe Dementia.
   Scuteri D, Rombolà L, Hayashi T, Watanabe C, et al · · 2022 · cited 5× · PMID 35956935 · DOI 10.3390/molecules27154987