EUCTR2010-019895-66-DE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 an Additional Two Years of Treatment - SCarlet RoAD
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
- •- 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:
- •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
- •- 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)
研究者
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