All-Russian Observational Non-interventional Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,583
- 主要终点
- Mean MoCA Score at Week 1 and the End of the 12-week Therapy
研究概览
简要总结
An open-label, prospective, observational, multicenter study. The study enrolls adult outpatients with CCI from 8 federal districts of the Russian Federation.
详细描述
Medical data (demographic and clinical characteristics - diagnosis, MoCA test results) are collected from patients to whom Divaza is prescribed to be taken according to the following regimen: 2 tablets 3 times per day for 12 weeks.
Neurologists assess the patients' cognitive functions with MoCA scale before starting therapy with Divaza (visit 1) and 12 weeks after the treatment (visit 2).
The efficacy of Divaza for the treatment of cognitive impairment in patients with chronic cerebral ischemia (CCI) is evaluated.
Safety is assessed based on the frequency and severity of adverse events. In addition, the relationship between MoCA test performance and gender or regional social and economic factors is evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either gender aged 18+ years.
- •Diagnosis of chronic cerebral ischemia (CCI) based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs.
- •Unchanged basic therapy of CCI and underlying vascular disease for a previous 3 month.
- •Signed informed consent form.
排除标准
- •Other neurological diseases.
- •Any known allergy to/intolerance of any constituent of the medication.
- •Pregnancy, breast-feeding.
- •Participation in other clinical trials for 3 months prior to enrollment in this study.
- •The patient is related to the research personnel of the investigative sites that are directly involved in the study, or is the immediate relative of the investigator, or the employee of OOO NPF Materia Medica Holding.
研究组 & 干预措施
Divaza
Oral administration. 2 tablet 3 times daily. Keep the tablets in the mouth until completely dissolved, outside of meal.
干预措施: Divaza (Drug)
结局指标
主要结局
Mean MoCA Score at Week 1 and the End of the 12-week Therapy
时间窗: week 1 to 12 week
MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome).MoCA test allows to evaluate the presence of cognitive impairment
次要结局
- The Number of Patients With a MoCA Score <26 at 12 Week(12 week)
- The Number of Patients With a MoCA Score ≤ 17 at the End of the 12-week Therapy(week1 to week 12)
- The Dynamics of Mean MoCA Score in Each Age Group(week1 to week 12)
- The Number of Patients With a MoCA Score Improvement (Increase in Scores) in Age Groups(week1 to week 12)