NCT01039701已完成2 期
Safety, Tolerability and Pharmacokinetics of 3 Dose Regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo Controlled, Parallel Group Phase IIa Study in Patients With Mild to Moderate Alzheimer's Disease During 4 Weeks of Treatment
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
- AstraZeneca
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Nature and incidence of adverse events
研究概览
简要总结
The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of progressive worsening of memory and other cognitive functions for at least 12 months
- •treatment with stable dose of donepezil (10 mg) for at least 3 months
- •the patient should have an appropriate caregiver, who is required for all study visits
排除标准
- •history of allergy/hypersensitivity reactions
- •significant neurological disease or dementia other than Alzheimer's disease
- •myocardial infarction or acute coronary syndrome within the last year
研究组 & 干预措施
4
Placebo Comparator
placebo + donepezil 10mg
干预措施: Placebo (Drug)
1
Experimental
AZD1446 60mg once daily + donepezil 10mg
干预措施: AZD1446 (Drug)
2
Experimental
AZD1446 60mg three times daily + donepezil 10mg
干预措施: AZD1446 (Drug)
3
Experimental
AZD1446 30mg three times daily + donepezil 10mg
干预措施: AZD1446 (Drug)
结局指标
主要结局
Nature and incidence of adverse events
时间窗: From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.
次要结局
- To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil(Twice during the study: at Visit 2 and Visit 10.)
- To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients(Twice during the study: at Visit 8 and Visit 10.)
- To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC(Baseline assessment at Visit 2 and a follow-up assessment at Visit 10)
研究者
研究点 (1)
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