NCT00171795已完成3 期
Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 67
- 主要终点
- 20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment
研究概览
简要总结
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic brain injury confirmed by available brain imaging (CT or MRI) and be at least 52 weeks post injury
- •Neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (SD) of the mean on the California Verbal Learning Test (CVLT) and impaired executive function (reduction of below 1 standard deviation (SD) of the mean on the Verbal Memory Learning Test (VLMT) and Tower of London Test (ToL) and impaired attention (reduction of below 1 standard deviation (SD) of the mean on the Test Battery for Attentional Performance (TAP)
- •Be required to have had sufficient education to read, write, and effectively communicate
- •Be cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver according to the investigator's judgement
排除标准
- •A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances
- •A current diagnosis of active, uncontrolled seizure disorder or major depression, or any other diagnosis that may interfere with the patient's response to study medication
- •An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations
- •Female patients with child-bearing potential who are breast-feeding, pregnant or not practicing non-hormonal contraception
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment
次要结局
- Safety of rivastigmine
- Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating
研究者
相似试验
终止
3 期
Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive ImpairmentCognitive SymptomsNCT00134953Novartis24
已完成
3 期
Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular DementiaVascular DementiaNCT00099216Novartis Pharmaceuticals708
招募中
3 期
Evaluation of the effect of rivastigmine on male patients with chronic schizophreniaIRCT20120314009297N8Mazandaran University of Medical Sciences60
已完成
1 期
Rivastigmine Study in Adolescents With Down SyndromeDown SyndromeNCT01084135Duke University42
招募中
3 期
Effectiveness of Rivastigmine and Donepezil on cognitive disordersIRCT20210819052232N1Esfahan University of Medical Sciences165