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

March 23, 2020 updated by: S.Anna Rehabilitation Institute

Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Defurocumarinized Bergamot Loaded in a Nanotechnological System for the Release of Essential Oil in the Treatment of Agitation in Severe Dementia Patients.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to the World Alzheimer's Report 2018, 50 million people worldwide suffer from dementia and it is estimated that this number will triple by 2050.

Very often people with dementia suffer from comorbidities accompanied by chronic, inflammatory and neuropathic pain, often under-diagnosed through psychological and behavioral symptoms of dementia such as agitation and aggression. The therapy of neuropsychiatric symptoms of dementia is currently based on the use of atypical antipsychotics that are actually present in the short term and may induce important side effects.

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. To solve this problem, this clinical trial will use defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of an odourless cream indistinguishable from placebo cream.

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.

The rationale of this clinical trial is based on three fundamental points:

  1. Preclinical research has proven, beyond any doubt, a powerful analgesic activity of BEO on inflammatory and neuropathic pain;
  2. at present the essential oils needed in aromatherapy for agitation management do not show strong analgesic activity, documented by extensive preclinical evidence;
  3. clinical trials that have assessed the efficacy of aromatherapy in neuropsychiatric symptoms associated with dementia suffer from the severe lack of a double-blind according to the most rigorous criteria of clinical trial evaluation. To solve this problem, this clinical trial will use defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of an odourless cream indistinguishable from placebo cream.

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years to 78 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BEO
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
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.
Placebo Comparator: Placebo
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
nanotechnological system loaded with placebo cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment of agitation
Time Frame: up to 6 weeks after the end of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the effect on agitation
Time Frame: 6 weeks after the end of treatment
Carry out a follow-up following suspension of the treatment with defurocumarinized bergamot loaded in a nanotechnology essential oil release system to assess the duration of the effect on agitation, using Cohen-Mansfield Agitation Inventory (CMAI) score. CMAI is a 29-item scale widely used to assess agitation.
6 weeks after the end of treatment
clinical efficacy on pain
Time Frame: 6 weeks after the end of treatment
Determine the clinical efficacy of defurocumarinized bergamot, loaded in a nanotechnological system of essential oil release in the pharmaceutical form of a cream, on pain in patients with severe dementia by determining the weekly score of the Mobilization-Observation-Behaviour-Intensity-Dementia (MOBID)-2 pain assessment scale. MOBID-2 is an extended version of the MOBID pain scale and consists of two parts: Part 1 is the previous MOBID and is used for the assessment of musculoskeletal pain through the observation of painful behaviour when performing five guided movements of different parts of the body in order to assign a score to the pain intensity; Part 2 is used for the assessment of pain from internal organs, head and skin, through behavioural indicators of pain and pain localization on the pain site illustrations.
6 weeks after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.Anna Rehabilitation Institute

Investigators

  • Principal Investigator: Paolo Tonin, MD, S.Anna Rehabilitation Insitute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

December 10, 2020

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISA-BEO092019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual partecipant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

1 year after the end of the study

IPD Sharing Access Criteria

Data access request will be reviewed by an internal audit committee in conjunction with a panel of university experts

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on defurocumarinized bergamot loaded in a nanotechnological essential oil release system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe