EUCTR2005-000063-25-GB进行中（未招募）1 期
A 26 week double-blind extension to a 26 week randomised, double-blind placebo-controlled study that evaluated the safety and efficacy of two different doses of phenserine-tartrate in patients with probable mild to moderate Alzheimer's disease.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Axonyx Inc
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •After successfully completing the AX-CL-09 study, patients will be enrolled in the extension study and will continue to receive study medication without a break (i.e. rollover directly into the extension study).
- •In order to be eligible for inclusion in this extension study, patients must have successfully completed the AX-CL-09 study and continue to fulfil the inclusion criteria for the AX-CL-09 study.
- •In addition, patients must fulfil the following:
- •General health status acceptable for participation in a 6 month extension study;
- •Are capable of understanding and have given written informed consent for the extension study [or this has been provided by their acceptable representative (according to local requirements)] and a separate caregiver responsibilities and consent form has also been signed by the patient’s caregiver;
- •Have a reliable caregiver available, and if not living in the same household, the caregiver sees the patient at least 4 times a week or a total of 15 to 20 hours per week;
- •Agrees to comply with the protocol requirements of the extension study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who complete the AX-CL-09 study may have received the investigational drug phenserine-tartrate, which is an acetylcholinesterase inhibitor. These patients are eligible for enrolment in the AX-CL-09e extension study providing they have not received any other acetylcholinesterase inhibitor in the 3 months before study entry, and providing they do not fulfil any other exclusion criteria from the AX CL-09 study.
研究者
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