CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease: A Phase 3 Randomised, Double-blind Placebo-controlled Trial of Rivastigmine to Prevent Falls in Parkinson's Disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 37
- 主要终点
- Fall rate
研究概览
简要总结
Parkinson's disease is a common condition particularly affecting older people. Falls are a very frequent complication of the disease affecting 60% of people with Parkinson's every year. As the population ages, the number of people living with Parkinson's disease and the occurrence of complications will increase. The loss of the chemical dopamine in the brain causes walking in Parkinson's to become slower, unsteady and irregular. People with the condition are therefore at a very high risk of falling. To some extent, people can compensate for these changes by paying more attention to their walking. However, Parkinson's also diminishes memory and thinking ability. This decreases people's ability to pay attention to their walking, especially when doing something at the same time.
Cholinesterase inhibitor (ChEis) are drugs that are currently used to treat people with memory problems in Parkinson's. The effect of these drugs on falls in Parkinson's has been tested to show that treatment has the potential to almost halve the number of falls.
This trial aims to definitively determine whether cholinesterase inhibitors (ChEi), can prevent falls in Parkinson's and whether this treatment is cost effective. 600 participants with Parkinson's disease will be enrolled from hospitals throughout the UK. Participants will be randomly assigned to either receive the drug (ChEi) via a patch or receive a placebo (dummy) treatment via a patch.
Neither the researchers nor the participants will know which group they are in. Participants will take the medication for 12 months and record any falls that they experience in diaries. If successful, this treatment in Parkinson's disease, would tackle one of the most disabling complications of the disease and positive findings will provide robust evidence to change clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease.
- •Modified Hoehn and Yahr stage 1-4 disease as determined at baseline visit.
- •Have experienced a fall in the previous year.
- •Able to walk ≥10m without aids or assistance.
- •18+ years of age.
排除标准
- •Previous ChEi use in 12 months prior to enrolment.
- •Hypersensitivity to rivastigmine
- •Dementia diagnosed according to MDS criteria (6).
- •Inability to attend or comply with treatment or follow-up scheduling.
- •Non-English-speaking patients (cognitive tests performed in English).
- •Falling ≥4x per day.
- •Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential.
- •Pregnancy and/or breastfeeding
研究组 & 干预措施
Active (Rivastigmine)
Rivastigmine Transdermal Patches
干预措施: Rivastigmine Transdermal System (Drug)
Placebo
Placebo Matched Transdermal Patches
干预措施: Placebo Transdermal System (Other)
结局指标
主要结局
Fall rate
时间窗: 12 months from the day the IMP is commenced
Fall rate measured using monthly diaries and telephone calls prospectively
次要结局
- Gait Assessment(12 months)
- Depression(12 months)
- Fear of falling(12 months)
- Participant health related quality of life(0,1,3,6 9 and 12 months)
- Apathy(12 months)
- Freezing of gait(12 months)
- Cognition(12 months)
- Parkinson's Disease (PD)(12 months)
- Frailty(12 months)
- Freezing of Gait Assessment(12 months)
- Capability of older people(12 months)
- Mortality (all cause and PD-related)(12 months)
- Cost effectiveness by NHS resource use(12 months)
- Physical performance(12 months)
- Dysphagia(12 months)