EUCTR2004-001100-12-HU进行中（未招募）不适用
A multi-centre, double-blind, parallel-group, randomised, placebo-controlled study to investigate the safety and tolerability of 0.25, 0.5 and 1.0 mg NS 2330 orally and once daily during a 14-week treatment period as add-on to 10 mg donepezil once daily in patients with mild to moderate dementia of the Alzheimer’s type.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •The population will include men and women, 40 to 85 years old with mild to moderate DAT based on the NINCDS-ADRDA criteria: MMSE 10-26 and a Hachinski score =4. Patients must have steady state conditions under donepezil (i.e. 10 mg once daily for at least 12 weeks), and a caregiver available for at least 24 hours/week.
- •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
- •Dementia secondary to other disorders; History of malignancy within the last 3 years; History or diagnosis of symptomatic and unstable/uncontrolled cardiovascular illnesses, liver disease such as cirrhosis, active hepatitis B and C, gastrointestinal disorders, and Renal disease; history of drug dependence or abuse; Known history HIV infection; Bodyweight < 50 kg; Planned elective surgery requiring general anaesthesia; Pregnancy.
研究者
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