The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Learning and Memory Measures.
研究概览
简要总结
The investigation will involve a double-blind, placebo controlled, cross-over study examining the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1 standard deviation below the mean on a brief cognitive screen will be given a thorough neuropsychological evaluation at two time points. Half of the patients will be randomized to receive a single oral dose of lactose placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •relapsing remitting and secondary progressive MS patients
- •between the ages of 18 and 60
- •report cognitive difficulties.
- •perform 1 sd or more below cut-off on cognitive screening measure
排除标准
- •no history of alcohol/drug abuse or nervous system disorder other than MS
- •no sensory impairments that might interfere significantly with cognitive testing
- •no developmental history of learning disability or attention-deficit/hyperactivity disorder
- •no medical condition other than MS that could substantially affect cognition
- •no relapse and/or corticosteroid use within four weeks of assessment;
- •no current use of modafinil, armodafinil or other psychostimulants.
研究组 & 干预措施
armodafinil and placebo
All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design
干预措施: armodafinil (Drug)
结局指标
主要结局
Learning and Memory Measures.
时间窗: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Testing was completed after first intervention and again after second intervention. Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75). RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15). Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36). BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12).
CPT -Test of Information Processing Speed
时间窗: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores. Continuous Performance Test (CPT) - Vigilance and reaction time.
Word Generation
时间窗: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
Stroop
时间窗: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
次要结局
未报告次要终点