NCT00630500已完成2 期
A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Clinical Global Impression of Change
研究概览
简要总结
A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of Parkinson's disease (Larsen and Dupont, 1994) and dementia (DSM IV(1987; 1994), or Dementia with Lewy bodies (McKeith et al. Neurology 2005)
- •mild-to-moderate or moderate dementia (i.e. MMSE 12-26, inclusive)
- •the subject has given a written informed consent
- •the subject is able and willing to comply with the study procedures and has a reliable caregiver (i.e. relative or nurse/nurse assistant who sees the patient at least weekly)
排除标准
- •other brain disease of sufficient severity to cause dementia
- •mental retardation
- •terminal illness with life expectancy shorter than 6 months
- •recent major changes in health status
- •known epilepsy or previous convulsive seizure
- •major depression
- •severe dementia as defined by a Mini-mental State Examination score of 12 or lower
- •moderate to severe renal impairment (i.e. serum creatinine > 1,5 upper limit normal (ULN) or creatinin clearance < 40ml/minute/1,73 m2
- •moderate or severe heart disease (NYHA III-IV)
- •moderate or severe pulmonal disease
- •moderate to severe hepatic impairment (bilirubin or transaminases > 2 times ULN
- •women of childbearing potential (i.e. not post-menopausal and not taking contraceptive
- •the subjects is lactating
- •any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the study physician
- •known allergies to the investigational product
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo matching active study drug
干预措施: Placebo (Drug)
Memantine
Active Comparator
Active treatment with memantine
干预措施: Memantine (Drug)
结局指标
主要结局
Clinical Global Impression of Change
时间窗: Month 3 and 6 after baseline
次要结局
- MMSE(Month 3 and 6)
- Alzheimer's QUick Test(Month 3 and 6)
- Cognitive Drug Research test(Month 3 and 6)
- Neuropsychiatric Inventory(Month 3 and 6)
- Unified Parkinson's Disease Rating Scale, part III(Month 3 and 6)
- Epworth Sleep Scale(Month 3 and 6)
- Stavanger Sleep Scale(Month 3 and 6)
研究者
研究点 (4)
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