NCT01255046Unknown2 期
A Phase II Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of STA-1 as an Add-on Treatment to Donepezil in Patients With Mild to Moderate Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change from baseline in ADAS-cog at Week 72
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of STA-1 vs placebo as an add-on treatment to donepezil in patients with mild to moderate Alzheimer's Disease (AD).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient aged ≥ 50 years;
- •Probable Alzheimer's disease diagnosed by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria;
- •MMSE score between 10-26, inclusive;
- •Patient has been treated with donepezil 10 mg per day for at least 3 months prior to screening;
- •Patient able to participate in all study evaluations and ingest oral medication as indicated;
- •Patient has a responsible caregiver who will accompany the patient to all clinic visits during the study;
- •Patient and the responsible caregiver have provided written informed consent before undergoing any study procedures.
排除标准
- •Brain image (computed tomography (CT) scan or Magnetic Resonance Imaging (MRI) done within past 12 months prior to the study) and laboratory tests to exclude secondary dementia or non-Alzheimer's dementia;
- •Patient with significant clinically central nervous system illness other than AD (e.g. Parkinson's disease, Human Immunodeficiency Virus (HIV) induced dementia, Hachinski Ischaemic Score (HIS) >4) or dementia complicated by other organic disease or delirium;
- •Patient with a severe or uncontrolled Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder;
- •Patient suffering from cerebral disturbances following a stroke or a cerebral trauma (if the event occurred within the last 6 months);
- •Patient with a history of hypersensitivity to study drugs;
- •Patient who has a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine (e.g., Addison's Disease), immune, neurologic, or hematologic disease as determined by the clinical judgment of the investigator;
- •Participation in any research study within the last 30 days;
- •Patient with significant alcohol or drug abuse as judged by the investigator.
研究组 & 干预措施
Donepezil plus STA-1
Active Comparator
干预措施: Donepezil, (Drug)
Donepezil plus STA-1
Active Comparator
干预措施: STA-1 (Drug)
Donepezil plus placebo
Placebo Comparator
干预措施: Donepezil, (Drug)
Donepezil plus placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in ADAS-cog at Week 72
时间窗: from baselline (Visit 2) to week 72 (Visit 9)
次要结局
- Change from baseline in Mini-Mental State Examination Scale Score (MMSE) at 72 week(baseline (V2) to week 72 (Visit 8))
研究者
研究点 (1)
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