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

NCT04321889 | Unknown DMC

• 1 other identifier: ISA-BEO092019
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Severe Dementia; Stroke

Outcome Measures

Primary Outcomes (1)

• Treatment of agitation

  To evaluate the clinical efficacy of defurocumarinized bergamot l in the treatment of agitation in patients with severe dementia by determination of the Cohen-Mansfield Agitation Inventory (CMAI)score. CMAI is a 29-item scale widely used to assess agitation.

  up to 6 weeks after the end of treatment

Secondary Outcomes (2)

• Duration of the effect on agitation

  6 weeks after the end of treatment

• clinical efficacy on pain

  6 weeks after the end of treatment

Study Arms (2)

BEO

EXPERIMENTAL

Subjects of both sexes of age \>65 years who have received diagnosis of severe dementia and clinically relevant agitation hospitalized in the enrolment center.

Device: defurocumarinized bergamot loaded in a nanotechnological essential oil release system

Placebo

PLACEBO COMPARATOR

Subjects of both sexes of age \>65 years who have received diagnosis of severe dementia and clinically relevant agitation hospitalized in the enrolment center.

Other: Placebo

Interventions

defurocumarinized bergamot loaded in a nanotechnological essential oil release system DEVICE

Patients will be treated either with placebo cream or with defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of cream 2 times a day for 4 weeks. The subject will be monitored throughout the treatment and for at least 4 weeks after the end of the treatment.

BEO

Placebo OTHER

nanotechnological system loaded with placebo cream

Placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of severe dementia by MMSE score\<12;
• Signature of informed consent by a family member/caregiver/support administrator;
• The use of authorised and concomitant therapies for the treatment of agitation is permitted.

You may not qualify if:

• Positive remote case history for pre-existing neurological or psychiatric disabling conditions

Sponsors & Collaborators

• S.Anna Rehabilitation Institute: lead

Related Publications (8)

• Scuteri D, Rombola L, Morrone LA, Bagetta G, Sakurada S, Sakurada T, Tonin P, Corasaniti MT. Neuropharmacology of the Neuropsychiatric Symptoms of Dementia and Role of Pain: Essential Oil of Bergamot as a Novel Therapeutic Approach. Int J Mol Sci. 2019 Jul 6;20(13):3327. doi: 10.3390/ijms20133327.

  PMID: 31284573 BACKGROUND

• Scuteri D, Morrone LA, Rombola L, Avato PR, Bilia AR, Corasaniti MT, Sakurada S, Sakurada T, Bagetta G. Aromatherapy and Aromatic Plants for the Treatment of Behavioural and Psychological Symptoms of Dementia in Patients with Alzheimer's Disease: Clinical Evidence and Possible Mechanisms. Evid Based Complement Alternat Med. 2017;2017:9416305. doi: 10.1155/2017/9416305. Epub 2017 Mar 30.

  PMID: 28465709 BACKGROUND

• Scuteri D, Crudo M, Rombola L, Watanabe C, Mizoguchi H, Sakurada S, Sakurada T, Greco R, Corasaniti MT, Morrone LA, Bagetta G. Antinociceptive effect of inhalation of the essential oil of bergamot in mice. Fitoterapia. 2018 Sep;129:20-24. doi: 10.1016/j.fitote.2018.06.007. Epub 2018 Jun 12.

  PMID: 29906556 BACKGROUND

• Sakurada T, Mizoguchi H, Kuwahata H, Katsuyama S, Komatsu T, Morrone LA, Corasaniti MT, Bagetta G, Sakurada S. Intraplantar injection of bergamot essential oil induces peripheral antinociception mediated by opioid mechanism. Pharmacol Biochem Behav. 2011 Jan;97(3):436-43. doi: 10.1016/j.pbb.2010.09.020. Epub 2010 Oct 13.

  PMID: 20932858 BACKGROUND

• Sakurada T, Kuwahata H, Katsuyama S, Komatsu T, Morrone LA, Corasaniti MT, Bagetta G, Sakurada S. Intraplantar injection of bergamot essential oil into the mouse hindpaw: effects on capsaicin-induced nociceptive behaviors. Int Rev Neurobiol. 2009;85:237-48. doi: 10.1016/S0074-7742(09)85018-6.

  PMID: 19607974 BACKGROUND

• Berliocchi L, Russo R, Maiaru M, Levato A, Bagetta G, Corasaniti MT. Autophagy impairment in a mouse model of neuropathic pain. Mol Pain. 2011 Oct 24;7:83. doi: 10.1186/1744-8069-7-83.

  PMID: 22023914 BACKGROUND

• Scuteri D, Pagliaro M, Mantia I, Contrada M, Pignolo L, Tonin P, Nicotera P, Bagetta G, Corasaniti MT; Pilot BRAINAID Trial investigators. Efficacy of therapeutic intervention with NanoBEO to manage agitation and pain in patients suffering from severe dementia: a pilot clinical trial. Front Pharmacol. 2024 Aug 1;15:1417851. doi: 10.3389/fphar.2024.1417851. eCollection 2024.

  PMID: 39148533 DERIVED

• Scuteri D, Sakurada S, Sakurada T, Tonin P, Bagetta G, Nicotera P, Corasaniti MT. Requirements for Translation in Clinical Trials of Aromatherapy: The Case of the Essential Oil of Bergamot (BEO) for Management of Agitation in Severe Dementia. Curr Pharm Des. 2022;28(20):1607-1610. doi: 10.2174/1381612828666220509152029.

  PMID: 35579159 DERIVED

MeSH Terms

Conditions

Dementia; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paolo Tonin, MD

  S.Anna Rehabilitation Insitute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loris Pignolo, Researcher

CONTACT

3996223973; l.pignolo@isakr.it

Loris Pignolo, Researcher

CONTACT

+3996223973; l.pignolo@isakr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blind placebo clinical trial for parallel groups 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 patients of both sexes with severe dementia diagnosis. Subjects will be eligible if they meet all inclusion criteria. A total of 134 patients will be enrolled, randomized, in a 1:1 ratio, to treatment with defurocumarinized bergamot loaded in a nanotechnological release system or placebo.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 25, 2020
• Study Start: April 1, 2020
• Primary Completion: December 10, 2020
• Study Completion: June 30, 2021
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year after the end of the study
• Access Criteria: Data access request will be reviewed by an internal audit committee in conjunction with a panel of university experts