Evaluating the Role of EGb 761 in the Syndrome of Mild Cognitive Impairment With Concomitant Cerebrovascular Disease (MCI + CVD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13)
研究概览
简要总结
EGb 761 has been demonstrated to be useful in improving cognitive and global clinical outcomes in patients with cognitive impairment or dementia, when administered at a daily dosage of 240mg in randomised controlled trials through several neuroprotective mechanisms of action. The study aims to determine the efficacy and safety profile of EGb 761 as a prescribed clinical drug for patients with MCI + CVD.
详细描述
EGb 761 has been demonstrated to be useful in improving cognitive and global clinical outcomes in patients with cognitive impairment or dementia, when administered at a daily dosage of 240 mg in randomised controlled trials through several neuroprotective mechanisms of action.
The study aims to determine the efficacy and safety profile of EGb 761 as a prescribed clinical drug for patients with MCI + CVD. This study is an open label 52-weeks study in subjects who have both MCI (based on the Petersen criteria and Albert MS criteria) and CVD. Eligibility for enrolment will be assessed initially at a screening visit, which is to occur within 42 days of baseline. 134 male and female subjects will participate and 67 of the 134 will receive the drug.
Subjects will be randomized to the EGB 761 arm and control arm in a 1:1 ratio using a block randomization method in groups of 4 subjects using an automated randomization software. The study will allow generating data in an Asian and multi-racial population and allows physicians to offer clinically efficacious and alternative treatment for patients with MCI + CVD.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with MCI based on the Petersen criteria and Albert MS criteria
- •Patients who have a Global Clinical Dementia Rating Score of 0.5
- •Patients aged 45 to 85 years at study entry
- •Patients who are literate and able to complete the cognitive evaluations in the opinion of the investigators
- •Patients with the presence of CVD, defined as the presence of white matter hyperintensities (WMH) of Fazekas grade 2 or 3 on MRI brain imaging (done up to 12 months prior to recruitment) or CT scans for patients contraindicated from MRI scans
- •Patients who provide written informed consent to participate in the study
排除标准
- •Participants should not be receiving antidepressants, antipsychotics, benzodiazepines, acetylcholinesterase inhibitors or NMDA antagonists during the study. Additionally, contraindications for EGb 761 as given in the local prescribing information/Summary of Product Characteristics (SmPC) should be observed.
研究组 & 干预措施
Tebonin Forte
Treatment: 120mg, twice a day, 52 weeks
干预措施: Tebonin Forte (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13)
时间窗: 52 weeks
Cognitive assessment
Clinical Dementia Rating Sum of Boxes Scores (CDR-SOB)
时间窗: 52 weeks
Functional assessment
次要结局
- Visual Cognitive Assessment Tool (VCAT)(52 weeks)
- Mild Behavioural Impairment Checklist (MBI-C)(52 weeks)