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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 134
- 主要终点
- Treatment of agitation
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Positive remote case history for pre-existing neurological or psychiatric disabling conditions
研究组 & 干预措施
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.
干预措施: defurocumarinized bergamot loaded in a nanotechnological essential oil release system (Device)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Treatment of agitation
时间窗: 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.
次要结局
- Duration of the effect on agitation(6 weeks after the end of treatment)
- clinical efficacy on pain(6 weeks after the end of treatment)