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

NCT04321889 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2020-03-25

No results posted yet for this study

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

Interventions

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.

OTHER

Placebo

nanotechnological system loaded with placebo cream

Sponsors & Collaborators

  • S.Anna Rehabilitation Institute

    lead OTHER

Principal Investigators

  • Paolo Tonin, MD · S.Anna Rehabilitation Insitute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2020-12-10
Completion
2021-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321889 on ClinicalTrials.gov