Neurology, Louisiana State University Health Sciences Center, New Orleans, LA 70003, USA.
Mult Scler. 2010 Jun;16(6):715-23. doi: 10.1177/1352458510367662. Epub 2010 May 18.
Memantine, an NMDA antagonist, is effective for moderate to severe Alzheimer's disease.
Determine whether memantine improves cognitive performance (CP) among subjects with multiple sclerosis (MS) and cognitive impairment (CI).
This double-blind, randomized, placebo-controlled trial (Clinicaltrials.gov NCT00300716) compared memantine 10 mg twice a day (4 week titration followed by 12 weeks on the highest tolerated dose) with placebo. The primary outcome was the change from baseline to exit on the Paced Auditory Serial Addition Test (PASAT) and the California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall (LDFR). Secondary outcomes included additional neuropsychological tests; self-report measures of quality of life, fatigue, and depression; and family/caregiver reports of subjects' CI and neuropsychiatric symptoms.
The differences between the groups on the change on the PASAT (placebo-memantine = 0.0 correct responses, 95% CI 3.4, 3.4; p = 0.9) and on CVLT-II LDFR (placebo-memantine =-0.6 words, 95% CI -2.1, 0.8; p = 0.4) as well as on the other cognitive tests were not significant. Subjects on memantine had no serious adverse events (AEs) but had more fatigue and neurological AEs as well as, per family members' reports, less cognitive improvement and greater neuropsychiatric symptoms than subjects on placebo.
Memantine 10 mg twice a day does not improve CP in subjects with MS, ages 18-65, without major depression, who have subjective cognitive complaints and perform worse than one SD below the mean on the PASAT or on the California Verbal Learning Test-II (total recall or delayed free recall).
NMDA 拮抗剂美金刚可有效治疗中重度阿尔茨海默病。
确定美金刚是否可改善多发性硬化症（MS）合并认知障碍（CI）患者的认知表现（CP）。
这是一项双盲、随机、安慰剂对照试验（Clinicaltrials.gov NCT00300716），将美金刚 10mg，每日 2 次（4 周滴定，然后用最高耐受剂量治疗 12 周）与安慰剂进行比较。主要结局是从基线到退出时的 paced auditory serial addition test（PASAT）和 california verbal learning test-II（CVLT-II）长延迟自由回忆（LDFR）的变化。次要结局包括其他神经心理学测试；生活质量、疲劳和抑郁的自我报告测量；以及患者的 CI 和神经精神症状的家庭/护理人员报告。
两组间 PASAT 变化（安慰剂-美金刚=0.0 个正确反应，95%CI3.4，3.4；p=0.9）和 CVLT-II LDFR 变化（安慰剂-美金刚=-0.6 个词，95%CI-2.1，0.8；p=0.4）以及其他认知测试的差异均无统计学意义。美金刚组无严重不良事件（AE），但疲劳和神经 AE 更多，且据家庭成员报告，认知改善更少，神经精神症状更多。
在无严重抑郁、主观认知主诉且 PASAT 或 california verbal learning test-II（总回忆或延迟自由回忆）得分低于均数 1 个标准差的 18-65 岁 MS 患者中，每日 2 次 10mg 美金刚不能改善 CP。
