NCT01137526已完成2 期
A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
AbbVie (prior sponsor, Abbott)30 个研究点 分布在 4 个国家目标入组 267 人开始时间: 2010年5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
- 267
- 试验地点
- 30
- 主要终点
- Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score
研究概览
简要总结
The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for adults with mild-to-moderate Alzheimer's Disease.
详细描述
This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.
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 and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
- •Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-
- •Subject meets the NINCDS/ADRDA criteria for probable AD.
- •Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit
- •Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit
- •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 12-lead ECG.
- •If female, subject must be postmenopausal for at least 2 years or surgically sterile.
- •If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
- •Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
- •Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficient visual, hearing and graphomotor skills to complete procedures.
排除标准
- •Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
- •Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
- •Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, excluding nicotine, within 2 years prior to Screening Visit
- •In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
- •The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
- •For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.
研究组 & 干预措施
ABT-384 Dose 2
Experimental
干预措施: ABT-384 (Drug)
ABT-384 Dose 1
Experimental
干预措施: ABT-384 (Drug)
donepezil
Active Comparator
干预措施: donepezil (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score
时间窗: 12 Weeks
次要结局
- Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12(12 Weeks)
- Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12(12 Weeks)
- Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12(12 Weeks)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12(12 Weeks)
研究者
研究点 (30)
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