NCT01764243已完成2 期
A Double-Blind, Placebo-Controlled Phase2 Study of MT-4666 in Patients With Mild to Moderate Probable Alzheimer's Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 450
- 主要终点
- Change from baseline in ADAS-cog-13
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy as assessed by the Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of MT-4666 or placebo administered daily for 24 weeks to subjects 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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA) criteria
- •MMSE score of 10 to 24 inclusive at screening and at Day 1, and CDR-SB score of ≥ 2 at screening
- •Modified Hachinski Ischemic Score (mHIS) ≤ 4 at screening
- •Caregiver available; caregiver sees subject at least four days (at least 12 hours) each week
- •Subject living at home; if living at senior residential setting, or an institutional setting, subject with caregiver indicated above is available
排除标准
- •Inability to perform cognitive tests (ADAS-cog-13 and MMSE) at screening and at Day 1
- •Diagnosis of any other disease which may cause dementia
- •MRI or CT scan within 6 months before screening, with findings inconsistent with the diagnosis of Probable AD
- •Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years
- •History of or current diagnosis of any psychosis
- •History of myocardial infarction or unstable angina within six months before screening
- •History of cerebrovascular disorder within 18 months before screening
研究组 & 干预措施
MT-4666 Low Dose
Experimental
low dose
干预措施: MT-4666 (Drug)
MT-4666 High Dose
Experimental
high dose
干预措施: MT-4666 (Drug)
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in ADAS-cog-13
时间窗: Baseline and Week 24
次要结局
- Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)(Baseline and Week 24)
- Change from baseline in Modified Crichton Scale(Baseline and Week 24)
- Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)(Baseline and Week 24)
- Change from baseline in Mini-Mental State Examination (MMSE)(Baseline and Week 24)
- Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11)(Baseline and Week 24)
- Change from baseline in Neuropsychiatric Inventory (NPI)(Baseline and Week 24)
研究者
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