NCT00088673Unknown3 期
A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer's Disease
Bellus Health Inc. - a GSK company72 个研究点 分布在 1 个国家目标入组 950 人开始时间: 2004年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 950
- 试验地点
- 72
- 主要终点
- The two primary efficacy parameters are the change from baseline to month 18 in the Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog) and the clinical Deterioration Scale Sum of Boxes (CDR-SB) scores.
研究概览
简要总结
The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.
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
- Double
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
- •Patients may be included in this study if they meet all of the following criteria:
- •Male or Female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
- •Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria).
- •Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
- •Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
- •Potential participant must be treated with conventional Alzheimer's disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
- •Fluency in English, French or Spanish (oral and written).
- •Signed informed consent from potential participant or legal representative and caregiver.
排除标准
- •Patients will not be eligible to participate in the study if they meet any of the following criteria:
- •Potential participant with any other cause of dementia.
- •Life expectancy less than 2 years.
- •Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
- •Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
- •Previous use of 3APS.
- •Patient recruitment is done by participating centers.
结局指标
主要结局
The two primary efficacy parameters are the change from baseline to month 18 in the Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog) and the clinical Deterioration Scale Sum of Boxes (CDR-SB) scores.
The brain volume change from baseline as measured by Magnetic Resonance Imaging will also be assessed.
次要结局
未报告次要终点
研究者
研究点 (72)
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