A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography and Event-Related Potentials in Patients With AD
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.
研究概览
简要总结
The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of probable Alzheimer´s Disease
- •Hachinski Ischaemic score < 4
- •MSE score 18 to 24
排除标准
- •History of any clinically significant disease or dementia other than Alzheimer´s Disease
- •Current major depressive disorder or other major psychiatric disorders
研究组 & 干预措施
1
2,5 mg once daily
干预措施: AZD1446 (Drug)
2
single dose of 5 mg
干预措施: Donepezil (Drug)
3
干预措施: Placebo (Drug)
4
60 mg once daily
干预措施: AZD1446 (Drug)
5
60 mg three times daily
干预措施: AZD1446 (Drug)
结局指标
主要结局
To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.
时间窗: collected from the time of informed consent is signed, throughout the study. The total study period is 9 weeks, divided into 5 equally long treatment periods of 7 days and 4 wash-out periods of 7 days each.
次要结局
- To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.(Information on these will be collected from the time of randomization, throughout the study.)
- To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable(Information on these will be collected from the time of informed consent is signed, throughout the study.)
- Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.(Information on these will be collected from the time of informed consent is signed, throughout the study.)