NeuroAiD Safe Treatment Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Number of patients experiencing adverse events
研究概览
简要总结
The NeST registry is a pro-active industry-academic collaboration to assess the use and safety of NeuroAiD in the real world setting. An online entry system was set up to allow easy data entry and retrieval of clinical information.
详细描述
The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional, and cognitive state, compliance, concomitant medications and side effects if any, among patients on NeuroAiD. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialization of NeuroAiD) and during subsequent visits. The follow up visits are timed with clinical appointments. Anonymized data will be extracted and collectively analyzed. Initial target sample size for the registry is 2000.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Taking, or has been prescribed NeuroAiD for any duration as judged by the physician and/or the participant
- •Agrees to be included in the registry and allows retrieval and analysis of data in accordance with local requirements
排除标准
- •Unwillingness to participate
- •Contraindication to NeuroAiD
结局指标
主要结局
Number of patients experiencing adverse events
时间窗: 3 months
Adverse events categorized according to individual events, organ system, severity (mild, moderate, severe), and relatedness (based on WHO-World Health Organization - Uppsala Monitoring System as 'possibly' 'probably' or 'definitely' related)
次要结局
- Functional outcome based on Bristol Activities of Daily Living (BADL)(3, 6, 9, 12)
- Functional status based on modified Rankin Scale(1, 2, 3 months)
- Neurological status based on Glasgow Coma Scale(1, 2, 3 months)
- Neurological status based on National Institute of Health Stroke Scale(1, 2, 3 months)
- Cognitive status based on Short Orientation-Memory-Concentration Test(1, 2, 3 months)
- Cognitive status based on Mini-Mental State Examination (MMSE)(3, 6,9, 12 months)
- Cognitive status based on Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog)(3, 6, 9, 12 months)
- Cognitive status based on Montreal Cognitive Assessment (MoCA)(3, 6, 9, 12 months)