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

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.

Sponsors

Lead Sponsor: S.Anna Rehabilitation Institute

Source S.Anna Rehabilitation Institute
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.

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.

Overall Status Not yet recruiting
Start Date April 1, 2020
Completion Date June 30, 2021
Primary Completion Date December 10, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Treatment of agitation up to 6 weeks after the end of treatment
Secondary Outcome
Measure Time Frame
Duration of the effect on agitation 6 weeks after the end of treatment
clinical efficacy on pain 6 weeks after the end of treatment
Enrollment 134
Condition
Intervention

Intervention Type: Device

Intervention Name: defurocumarinized bergamot loaded in a nanotechnological essential oil release system

Description: 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.

Arm Group Label: BEO

Intervention Type: Other

Intervention Name: Placebo

Description: nanotechnological system loaded with placebo cream

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 65 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Paolo Tonin, MD Principal Investigator S.Anna Rehabilitation Insitute
Overall Contact

Last Name: Loris Pignolo, Researcher

Phone: 3996223973

Email: [email protected]

Verification Date

March 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: BEO

Type: Experimental

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

Label: Placebo

Type: Placebo Comparator

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

Acronym BEO
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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.

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov