NCT01018875已完成2 期
A Randomized, Double-Blind, Active- and Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
AbbVie (prior sponsor, Abbott)21 个研究点 分布在 2 个国家目标入组 242 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 21
- 主要终点
- ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
研究概览
简要总结
Efficacy and safety study of ABT-288 in adults 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have voluntarily signed an informed consent.
- •Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease).
- •Female subjects must be postmenopausal for at least 2 years or surgically sterile.
- •Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control.
- •Subject has an identified, reliable caregiver.
- •Subject has a CT or MRI scan within 36 months prior to randomization.
- •With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and ECG
排除标准
- •Subject is currently taking or has taken a medication for the treatment of AD or dementia with 60 days of Screening visit, or is participating in cognitive therapy for the treatment of AD or dementia.
- •Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
- •Subject has a history of any significant neurologic disease other than AD.
- •Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
- •Subject has received any investigation product within 6 weeks prior to study drug administration.
研究组 & 干预措施
Arm 1, Dose 1, ABT-288
Experimental
Low Dose
干预措施: ABT-288 (Drug)
Arm 2, Dose 2, ABT-288
Experimental
High dose
干预措施: ABT-288 (Drug)
donepezil
Active Comparator
干预措施: donepezil (Drug)
sugar pill
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
时间窗: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
次要结局
- MMSE: Mini Mental Status Exam(Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD)
- NPI: Neuropsychiatric Inventory(Day -1, Weeks 4,8, 12/PD)
- CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus(Day -1, Weeks 4,8 & 12/PD])
- ADCS-ADL: Alzheimer's Disease Cooperative Study(Day -1, Weeks 4,8 & 12/PD)
研究者
研究点 (21)
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