Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall
研究概览
简要总结
The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.
详细描述
This is a pilot/feasibility study of memantine in severe traumatic brain injury (TBI) persons, employing a randomized, double-blind, placebo-controlled, design. Outcome evaluations will occur after 24 weeks of treatment (on medication) and 4 weeks after treatment discontinuation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18-65 years old of age at time of enrollment
- •Severe traumatic brain injury (TBI)
- •Feeding access (e.g., orogastric (OG), nasogastric (NG), or percutaneous endoscopic gastrostomy (PEG) tube) permitting delivery of memantine or placebo
- •Availability of legally-authorized representative (LAR) to provide consent and participate in some study activities (e.g., monitoring for side effects, providing information about the patient)
排除标准
- •Pre-existing history of serious neurological disorder
- •Pre-existing history of serious psychiatric disorder (e.g., schizophrenia)
- •Anticipated poor prognosis, based on the presence of bilaterally fixed and dilated pupils, severe hemodynamic instability, severe elevations in intracranial pressure refractory to interventions, or other factors leading to a determination of a probable non-survivable injury
- •Primarily penetrating mechanism of injury (e.g., gunshot wound to the head)
- •Isolated epidural hematoma with anticipated good prognosis
- •Low probability of participant being compliant or being able to finish study procedures (e.g., present for outcome rating) in the judgment of the investigator
- •Not English speaking (due to inability to complete outcome measure)
- •Medical contraindications to memantine: Severe hepatic impairment (defined as albumin > 15gm/dL, Alk Phos > 375 U/L, ALT > 150 U/L, AST > 120 U/L or bilirubin > 3mg/dL). Moderate-to-Severe renal impairment (defined as creatinine clearance < 60)
- •Pregnancy or breastfeeding
研究组 & 干预措施
Memantine
24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
干预措施: Memantine (Drug)
Placebo
24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
干预措施: Placebo (Drug)
结局指标
主要结局
California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall
时间窗: Week 24
Neuropsychological test used to assess an individual's verbal memory abilities. The California Verbal Learning Test-Second Edition (CVLT-II) Long Delay Free Recall measures total word list items recalled after a 20-minute delay. The raw score is converted to a Z-score (Mean=0; SD=1) which was used for statistical analysis. Higher scores reflect worse performance (i.e., more recall errors) on this variable.
次要结局
- Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall(Week 24)
- CVLT-II Trials 1-5 Free Recall Total(Week 24)
- BVMT-R Learning(Week 24)
- Trail Making Part B(Week 24)
- Stroop Interference(Week 24)
- Behavior Rating Inventory of Executive Function (BRIEF) Inhibit(Week 24)
- Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger)(Week 24)
研究者
Flora Hammond
Covalt Professor & Chair
Indiana University