NCT02327182终止3 期
A Long-Term Safety Study of MT-4666 in Patients With Mild to Moderate Alzheimer's Disease (AD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimer's disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD).
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
- None
入排标准
- 年龄范围
- 55 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 the National Institute on Aging and the Alzheimer's Association Criteria for Diagnosis of Alzheimer's Disease (McKhann et al. 2011).
- •MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline.
- •Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening
- •Appropriate caregiver available
- •Subject living at home or in facilities who do not require continuous (24-hour) nursing care.
排除标准
- •Diagnosis of any other disease which may cause dementia
- •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
- •complication of hepatic disorder or renal dysfunction
研究组 & 干预措施
MT-4666 low dose
Experimental
Low Dose, Tablet, Once Daily, For 52 Weeks
干预措施: MT-4666 (Drug)
MT-4666 high dose
Experimental
High Dose, Tablet, Once Daily, For 52 Weeks
干预措施: MT-4666 (Drug)
结局指标
主要结局
Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimer's disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: Up to week 56
次要结局
- Change in Neuropsychiatric Inventory (NPI) total score(baseline to Week 52)
- Change in Mini Mental State Examination (MMSE)(baseline to Week 52)
研究者
研究点 (1)
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