NCT00663936已完成2 期
A Phase 2a Multi-center, Randomized, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of T-817MAa in Patients With Mild to Moderate 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
- 373
- 试验地点
- 35
- 主要终点
- Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (post-menopausal or surgically sterile)
- •Patients with Mild to moderate Alzheimer's disease who are receiving Donepezil.
- •Age 50 to 90 inclusive
- •Patients must be living in the community
- •Patients must have an eligible informant or study partner (caregiver)
- •Patients and eligible informant or study partner (caregiver) must be able to read and understand English.
- •Informed consent obtained from both the patient and the caregiver etc (According to the protocol)
排除标准
- •Patients with clinically significant cardiac, hepatic or renal impairment
- •Patient have a dementia not of the Alzheimer's type etc (According to the protocol)
- •Patients who are taking any drug other than donepezil for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda™) or tacrine (Cognex®) taken within twelve (12) weeks of the Baseline Visit (Visit 2).
研究组 & 干预措施
1
Experimental
T-817MA once daily
干预措施: T-817MA (Drug)
2
Placebo Comparator
Placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
时间窗: 52 weeks
次要结局
- Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.(52 weeks)
研究者
研究点 (35)
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