NCT00608946已完成2 期
Treatment With Copper in Patients With Mild Alzheimer´s Dementia
University Hospital, Saarland0 个研究点目标入组 68 人开始时间: 2004年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 主要终点
- change of cognitive function, measured by ADAS-cog
研究概览
简要总结
The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid protein in the CSF and volumetric changes in the brain will be examined in a first double-blind, placebo-controlled human clinical trial conducted in 70 patients with mild Alzheimer´s dementia.
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
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients
- •between 50 and 80 years
- •criteria of mild dementia
- •probable Alzheimer´s dementia according to NINCDS-ADRDA criteria
- •given written informed consent
- •having a relative who can fill out questionnaire; caregiver consent
- •free of serious and unstable somatic illness
排除标准
- •unable to give informed consent
- •unable to take cholinesterase inhibitors
- •unapproved medication
- •moderate to severe Alzheimer´s disease
- •dementia of other etiology
- •history of alcohol, drug or medication abuse
- •other psychiatric disorder, e. g. schizophrenia
- •known copper and zinc storage disease
- •known copper and zinc intolerance
- •known severe allergies or intolerances
- •insufficient knowledge of the German language
- •female patients of childbearing potential, pregnant or nursing patients
- •participation in a clinical trial within the past 30 days before onset of this study
- •severe somatic diseases and high mortality rate AST, ALT, GGT, GLDH, AP or bilirubin being a two-fold above the normal range
研究组 & 干预措施
2
Placebo Comparator
placebo
干预措施: placebo (Dietary Supplement)
1
Experimental
efficacy of the intake of 8 mg of copper daily per os for one year under observation of cognitive status unless unacceptable side effects appear
干预措施: copper (Dietary Supplement)
结局指标
主要结局
change of cognitive function, measured by ADAS-cog
时间窗: one year
次要结局
- change of beta amyloid in the CSF and volumetric changes in the brain(one year)
研究者
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