NCT00948909已完成2 期
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease
AbbVie (prior sponsor, Abbott)29 个研究点 分布在 6 个国家目标入组 274 人开始时间: 2009年10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
- 274
- 试验地点
- 29
- 主要终点
- ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
研究概览
简要总结
This is a efficacy and safety study evaluating new treatment for subjects with mild to moderate Alzheimer's Disease.
详细描述
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined:
- MMSE - Mini Mental Status Exam
- QoL-AD - Quality of Life - Alzheimer's Disease
- CIBIC-plus - Clinician Interview-Based Impression of Change
- NPI - Neuropsychiatric Inventory
- CSDD - The Cornell Scale for depression in Dementia
- ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living
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
- Triple (Participant, Care Provider, Investigator)
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
- •The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit
- •The subject meets the NINCDS/ADRDA criteria for probable AD.
- •The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit
- •The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit
- •If female, subject must be postmenopausal for at least two years or surgically sterile
- •The subject has an identified, reliable, caregiver.
排除标准
- •The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1
- •The subject has a history of any significant neurologic disease other than AD.
- •In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
- •The subject has reported history of discontinuation of donepezil due to lack of efficacy.
- •The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
- •The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations.
- •Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
- •Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).
研究组 & 干预措施
A. Sugar Pill
Placebo Comparator
干预措施: Placebo (Drug)
B. ABT-126
Experimental
干预措施: ABT-126 (Drug)
C. ABT-126
Experimental
干预措施: ABT-126 (Drug)
D. donepezil
Active Comparator
干预措施: donepezil (Drug)
结局指标
主要结局
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
时间窗: Measurements up through 12 weeks.
次要结局
- MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description.(Measurements up through 12 weeks.)
研究者
研究点 (29)
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