NCT01024660已完成早期 1 期
A Randomised, Double-blind, Placebo-controlled, Parallel Design, Multicentre Study in Patients With Mild to Moderate Alzheimer's Disease to Investigate the Effect on Cognitive Function as Measured by Repeated CogState Testing in Relation to Effects on Traditional Cognitive Measures After 12 Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- CogState Computerized Neurological Test Battery
研究概览
简要总结
The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 AD according to NINCDS-ADRDA criteria.
- •The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patient's home.
- •Patient and caregiver should understand, speak, and read local language.
排除标准
- •Significant neurological disease or dementia other than AD, e.g., mixed dementia, frontotemporal dementia, and Parkinson's Disease.
- •Females of child bearing potential
- •Impaired vision or hearing
研究组 & 干预措施
1
Active Comparator
5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)
干预措施: Donepezil (Drug)
2
Placebo Comparator
干预措施: Placebo to match Aricept (Drug)
结局指标
主要结局
CogState Computerized Neurological Test Battery
时间窗: Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98
次要结局
- Neuropsychological Test Battery (NTB)(Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97)
- Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog)(Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97)
- Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)(Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to PlaceboHypercholesterolemiaNCT02957682Regeneron Pharmaceuticals2,176
已完成
2 期
Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's DiseaseCentral Nervous System DiseasesCognitionAlzheimer's DiseaseNCT01073228FORUM Pharmaceuticals Inc409
已完成
2 期
Safety and Cognitive Function Study of EVP-6124 in Patients With SchizophreniaCentral Nervous System DiseasesCognitionSchizophreniaNCT00968851FORUM Pharmaceuticals Inc317
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic CardiomyopathyObstructive Cardiomyopathy, HypertrophicNon-obstructive Hypertrophic CardiomyopathyNCT06481891Lexicon Pharmaceuticals500
已完成
2 期
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's DiseaseSevere Alzheimer DiseaseNCT03765762Alkahest, Inc.26