NCT00934375已完成4 期
A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 145
- 试验地点
- 47
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events
研究概览
简要总结
This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).
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
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Range: Adult subjects (45 to 90 years of age inclusive)
- •Sex distribution: Men and women. Women of child-bearing potential (<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. [Women who are breast-feeding are excluded.]
- •Subjects must have completed the one year, double-blind core trial (E2020-A001-412).
- •A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia.
- •Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
- •The subject must be expected to complete the entire study.
- •Subjects must be sufficiently fluent in English.
- •Subjects must have an informant who has daily contact with the subject (e.g., an average of 10 or more hours per week), can observe for possible adverse events and will accompany the subject to all visits.
- •Clinical laboratory values must be within normal limits, or if abnormal, judged clinically insignificant by the investigator (not likely to cause cognitive impairment or medical instability).
排除标准
- •Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412).
- •Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412).
- •Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia.
- •Subjects with uncontrolled hypertension (sitting systolic >= 160mmHg and/or diastolic >=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.
- •Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic disease.
- •Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline.
- •Subjects who may not be able to comply with the protocol.
- •Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors.
- •Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of >170mg/dl.
- •Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
- •Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).
研究组 & 干预措施
2
Placebo Comparator
干预措施: placebo (Drug)
1
Experimental
干预措施: Aricept (donepezil hydrochloride) (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events
时间窗: Baseline, Week 6, Week 12 and Week 28.
Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)
次要结局
未报告次要终点
研究者
研究点 (47)
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