Efficacy and Tolerability of MLC601 in Patients With Mild to Moderate Alzheimer Disease Who Were Unable to Tolerate or Failed to Benefit From Treatment With Rivastigmine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements
研究概览
简要总结
Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer disease (AD) offer limited and often transient symptomatic benefits to patients but do not mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with Rivastigmine.
详细描述
An 18-month open-label pilot study would be conducted at three university referral centres in Tehran, Iran. All patients are at least 50 years old, met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and failed treatment with the cholinesterase inhibitor Rivastigmine for any reason. A baseline medical history will be taken and physical examination will be performed for all participants, and any comorbidities and concomitant therapies would be noted. Patients with controlled concomitant diseases, such as hypertension and diabetes, will be allowed to enter the study. Mini-Mental State Examination (MMSE)10 and Alzheimer disease assessment scale-cognitive sub scale11 (ADAS-cog) will be used to measure treatment efficacy. MLC601 will be prescribed as one capsule three times daily without an escalation dose. Safety and tolerability evaluations included physical examinations, electrocardiography, vital sign monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter. The MMSE and ADAS-cog will be recorded at each efficacy follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 50 years old
- •met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- •failed treatment with the cholinesterase inhibitor Rivastigmine for any reason
排除标准
- •uncontrolled diabetes mellitus
- •hypertension
- •unstable cardiac disease
- •severe obstructive pulmonary disease
- •renal or hepatic failure
- •and/or other life threatening conditions
研究组 & 干预措施
MLC601
MLC601 (NeuroAid, Moleac Pte. Ltd, Singapore) (0.4 g per capsule) was prescribed as one capsule three times daily without an escalation dose.
干预措施: MLC601 (Drug)
结局指标
主要结局
changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements
时间窗: every 4 weeks up to 18 months
change in the Mini-Mental State Examination (MMSE) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.
changes in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements
时间窗: every 4 weeks up to 18 months
change in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.
次要结局
- to measure included adverse events (AEs)(every 4 weeks)
- measuring withdrawal rate(every 4 weeks)
研究者
Ali Amini Harandi
Dr
Shahid Beheshti University of Medical Sciences