Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- olfactory function
研究概览
简要总结
There is convincing evidence from numerous studies using both psychophysical and electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49% in the pioneering studies of Ansari & Johnson, and Ward, respectively, up to 74% in the work of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life, safety, and interpersonal relations, as well as food behavior/nutritional intake are severely altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed in patients with Parkinson's disease. If it was possible to improve olfactory function this would appear as a significant effect in patients with Parkinson's disease. Provided the study would reveal an improvement of olfactory function following therapy with rasagiline, this would have tremendous worldwide impact on the use of this drug. Considering the frequency of PD a very large number of patients would benefit from these findings, especially in terms of quality of life.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson´s disease, Hoehn & Yahr stage ≤ III
- •aged 18-64 yrs
- •hyposmia/functional anosmia defined as TDI<30
- •written consent
排除标准
- •congenital olfactory loss
- •significant infections of the nose and nasal sinuses
- •diseases/states apart from PD which may significantly affect olfactory function, e.g., asthma, head trauma etc.
- •dementia, psychiatric illness, addictive behaviour
- •severe liver disease
- •pregnant or breastfeeding women
- •any contraindication for the treatment with Rasagiline
- •women without reliable contraception
研究组 & 干预措施
Rasagiline
干预措施: Azilect 1mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
olfactory function
时间窗: 4 months
次要结局
- quality of life(4 months)
