ISRCTN41639809已完成3 期
CHIEF-PD (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
niversity of Bristol0 个研究点目标入组 600 人开始时间: 2019年4月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
2021 Protocol article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8556953/ (added 15/02/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 05/07/2019:
- •1. Diagnosis of idiopathic Parkinson’s disease
- •2. Modified Hoehn and Yahr stage 1-4 disease
- •3. Have experienced a fall in the previous year
- •4. Able to walk =10m without aids or assistance
- •5. 18 years of age or above
- •Previous participant inclusion criteria:
- •1. Diagnosis of idiopathic Parkinson’s disease
- •2. Modified Hoehn and Yahr stage 1-4 disease
- •3. Have experienced a fall in the previous year
- •4. Able to walk =10m without aids or assistance
排除标准
- •Current participant exclusion criteria as of 05/07/2019:
- •1. Previous ChEi use in 12 months prior to enrolment.
- •2. Hypersensitivity to rivastigmine
- •3. Dementia diagnosed according to Movement Disorder Society (MDS) criteria
- •4. Inability to attend or comply with treatment or follow-up scheduling
- •5. Non-English-speaking patients (cognitive tests performed in English)
- •6. Falling = 4x per day
- •7. Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential
- •8. Pregnant of breast feeding
- •Previous participant exclusion criteria:
- •1. Previous ChEi use in 12 months prior to enrolment
- •2. Hypersensitivity to rivastigmine
- •3. Dementia diagnosed according to Movement Disorder Society (MDS) criteria
- •4. Inability to attend or comply with treatment or follow-up scheduling
- •5. Non-English-speaking patients (cognitive tests performed in English)
- •6. Falling = 4x per day
- •7. Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential
研究者
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