EUCTR2010-019895-66-DK进行中（未招募）1 期
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease with Option for up to an Additional Two Years of Treatment and up to Three Years of an Open-Label Extension with Active Study Treatment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 797
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult patients, 50-85 years of age
- •- Patients with prodromal Alzheimer's Disease who are not receiving memantine or cholinesterase inhibitors
- •- Has a study partner who is able to provide accurate information as to the patient's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion
- •- Has had sufficient education or work experience to exclude mental retardation
- •- Study partner has noticed a recent gradual decrease in patient's memory (e.g. over the last 12 months), which the patient may or may not be aware of
- •- Screening MMSE score of 24 or above
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 154
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 616
排除标准
- •- Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning
- •- A history of stroke
- •- A documented history of transient ischemic attack within the last 12 months
- •- History of schizophrenia, schizoaffective or bipolar disorder
- •- Currently meets criteria for major depression
- •- Within the last 2 years, unstable or clinical significant cardiovascular disease (e.g. myocardial infarction, angina pectoris)
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