NCT01527916已完成2 期
A Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
AbbVie (prior sponsor, Abbott)33 个研究点 分布在 6 个国家目标入组 438 人开始时间: 2012年2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
- 438
- 试验地点
- 33
- 主要终点
- Alzheimer's Disease Assessment Scale - cognitive subscale
研究概览
简要总结
This is an efficacy and safety study evaluating a 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 410 adults with mild to moderate Alzheimer's disease. Subjects will be randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-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 an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.
- •The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit
- •The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease.
- •The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit
- •The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit
- •The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit
- •With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
- •The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.
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, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia.
- •The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
- •The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- •In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
- •The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
研究组 & 干预措施
sugar pill
Placebo Comparator
干预措施: placebo (Drug)
donepezil
Active Comparator
干预措施: donepezil (Drug)
ABT-126 Low Dose
Experimental
low dose
干预措施: ABT-126 (Drug)
ABT-126 Middle Dose
Experimental
middle dose
干预措施: ABT-126 (Drug)
ABT-126 high dose
Experimental
high dose
干预措施: ABT-126 (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale - cognitive subscale
时间窗: Measurements up through 24 weeks
次要结局
- Clinician Interview-Based Impression of Change - plus (CIBIC-plus)(Measurements up through 24 weeks)
- Neuropsychiatry Inventory (NPI)(Measurements up through 24 weeks)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)(Measurements up through 24 weeks)
- Mini Mental Status Exam (MMSE)(Measurements up through 24 weeks)
- DEMentia Quality of Life (DEMQOL)(Measurements up through 24 weeks)
- Partner-Patient Questionnaire for Shared Activities (PPQSA)(Measurements up through 24 weeks)
- Resource Use in Dementia (RUD-Lite)(Measurements up through 24 weeks)
- EuroQol-5D Questionnaires(Measurements up through 24 weeks)
- Wechsler Memory Scale-III (WMS-III) Working Memory Index(Measurements up through 24 weeks)
研究者
研究点 (33)
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