NL-OMON44866已完成4 期
Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson*s disease: a multi-center placebo-controlled trial (CHEVAL) - CHEVA
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. idiopathic PD with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry (in accordance with clinical diagnostic criteria of the UK PD Society Brain Bank);;2. the presence of minor visual hallucinations for at least 4 weeks, defined by a score of 1 or 2 on the hallucinations item of the Unified Parkinson*s Disease rating Scale (UPDRS)1-MDS;;3. age 40 years and over.
排除标准
- •1. Parkinson's disease associated psychosis, defined as the need for antipsychotic drug treatment in the opinion of the treating neurologist;;2. Parkinson's disease dementia, defined by a score of 26 or lower on the Mini Mental State Examination (MSSE);;3. current delirium (caused by infection or metabolic disturbance);;4. current treatment with drugs that have important central anticholinergic effects;5. current or recent (< 6 months) treatment with Cholinesterase inhibitors, such as rivastigmine (Exelon) or galantamine (Reminyl);;6. VH in response (<= 1 month) to increase of dopamingergic treatment;;7. history of psychosis, (known) sick sinus syndrome or other arrhythmia ;8. current severe ophtalmologic disease (defined as a visual acuity score of < 0.5 based on Snellen eye test';;9. permanent stay in a nursing home;;10. no informed consent.
研究者
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