NCT00217763Unknown3 期
A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease
Bellus Health Inc. - a GSK company77 个研究点 分布在 9 个国家目标入组 930 人开始时间: 2005年9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
- 930
- 试验地点
- 77
研究概览
简要总结
The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.
详细描述
- Duration of treatment: 18 months
- 3 treatment arms:
Placebo and 2 different doses of active drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES.
- •INCLUSION CRITERIA:
- •Participants must meet the following inclusion criteria to be eligible.
- •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 an acetylcholinesterase inhibitor (donepezil, galantamine or rivastigmine) and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
- •Participants must not have taken memantine for at least 4 months prior to the commencement of screening. The use of memantine is prohibited during the course of the study.
- •Fluency (oral and written) in the language in which the standardized tests will be administered.
- •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.
- •Previous use of anti-amyloid or vaccine treatment for Alzheimer's disease.
- •Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
- •Previous exposure to 3APS.
- •Inability to swallow pills.
研究者
研究点 (77)
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