COMPARISON OF COGNITIVE, BEHAVIORAL EFFECTS OF LEVETIRACETAM, CARBAMAZEPINE

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项双盲、随机、两期交叉研究，比较了常用抗癫痫药物左乙拉西坦和卡马西平对正常健康志愿者的认知和行为影响。这项研究包括在25周内进行12次访问。45名正常健康受试者将同时接受左乙拉西坦(2000毫克/天)和卡马西平[调整剂量以获得中等抗惊厥血药水平(ABL)，目标ABL=8.5微克/毫升，范围为6-12微克/毫升]，每个治疗8周。在每个AED治疗期之后，将在本月剩余时间内进行四天的缩减和AED冲洗期。认知和行为功能测试以及安全测试将在预处理基线、每个随机化AED维护期结束时以及最终冲洗期之后进行。具体目标：拟议研究的总体目标是比较左乙拉西坦和卡马西平在健康成年人治疗8周后对神经心理功能的影响。我们还计划在健康成年人中比较左乙拉西坦和卡马西平的安全性和耐受性。假设：我们的假设是卡马西平的认知效应将大于左乙拉西坦。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a double-blind, randomized, two period crossover study comparing the cognitive and behavioral effects of the commonly-prescribed antiepileptic drugs (AEDs) levetiracetam and carbamazepine in normal healthy volunteers. The study consists of 12 visits over a 25 week period. Forty five (45) normal healthy subjects will be treated with both levetiracetam (2000 mg/day) and carbamazepine [adjusted to a dose to obtain mid-range anticonvulsant blood level (ABL) with a target ABL = 8.5¿¿g/ml and a range = 6-12 ¿¿g/ml) for 8 weeks each. Each AED treatment period will be followed by a four day taper and washout period off AED for the remainder of the month. Cognitive and behavioral function testing along with safety testing will be conducted at pretreatment baseline, the end of each randomization AED maintenance period, and after the final washout period. SPECIFIC AIMS: The overall aim of the proposed study is to compare the effects of levetiracetam versus carbamazepine on neuropsychologic function after eight weeks treatment in healthy adults. We also plan to compare the safety and tolerability of levetiracetam versus carbamazepine in healthy adults. Hypothesis: Our hypothesis is that the cognitive effects of carbamazepine will be greater than those of levetiracetam.