CARBAMAZEPINE TRIAL IN AGITATED ALZHEIMER'S OUTPATIENTS

这是一个随机分配的建议，双盲，安慰剂- 卡马西平治疗66例疑似和疑似AD的临床对照研究 临床上有显著行为障碍的门诊患者。这个 研究持续时间为6周，筛查期为10至7天(运行- In)。受试者将每两周进行一次疗效评估，使用 由评分员验证的仪器对治疗条件视而不见。一家诊所 监视谁愿意接受调解状态将每周评估受试者以 加强安全保障。最初分配给安慰剂的受试者将被提供 在类似研究条件下进行为期六周的药物开放试验。 在六周的审判之后，将会有一个公开的，不受控制的， 持续24周的持续阶段以评估安全性、药物 自动新陈代谢，并持续有效。病人将按月就诊。 随访的间隔时间。 这项研究的目的是比较卡马西平(400至300 mg/d) 安慰剂对照治疗的疗效和副作用 焦虑的阿尔茨海默病患者。疗效的衡量标准包括短暂的精神病学 评定量表(BPRS)、临床总体改善量表(CGI)、汉密尔顿 抑郁评定量表，亲属对全球范围的评估 症状学--老年人(RAGS-E)、身体自我维持量表和 日常生活工具活动(PSMS/IADL)。初级阶段 临床反应标准为大于或等于30% 改善了BPR的激荡系数，并有了很大的改善 对CGI的评级。定义了卡马西平的最小效应量 (r=0.18)。 第二个目标是复制先前的观察结果，即血小板 ~3H-丙咪嗪结合B(Max)降低，MAO活性相对降低 与有症状行为的阿尔茨海默病患者相比， 阿尔茨海默病患者无症状行为。

This is a proposal for a random assignment, double-blind, placebo- controlled clinical trial of carbamazepine in 66 probable and possible AD outpatients with clinically significant behavioral disorders. The duration of study is six weeks with a 10 to 7 day screening period (run- in). Subjects will be assessed for efficacy at biweekly intervals using validated instruments by raters blind to treatment condition. A clinical monitor who is open to mediation status will evaluate subjects weekly to enhance safety. Subjects originally assigned to placebo will be offered an open six week trial of medication under similar study conditions. After the six week trial, there will be an open, uncontrolled, continuation phase of 24 week's duration to assess safety, drug autometabolism, and continuing efficacy. Patients will be seen at monthly intervals for follow-up. The objective of this study is to compare carbamazepine (400 to 300 mg/d) to a placebo control in terms of efficacy and side effects in treating agitated AD patients. Measures of efficacy include the Brief psychiatric Rating Scale (BPRS), Clinical Global Improvement Scale (CGI), Hamilton Rating Scale for Depression, Relatives' Assessment of Global Symptomatology-Elderly (RAGS-E), the Physical Self-Maintenance Scale and Instrumental Activities of Daily Living (PSMS/IADL). The primary criterion for clinical response is a greater than or equal to 30% improvement on the agitation factor of the BPRS, and a 'much improved' rating on the CGI. A minimum effect size for carbamazepine is defined (r=0.18). A secondary objective is to replicate a prior observation that platelet 3H-imipramine binding B(max) is decreased, and MAO activity is relatively decreased in Alzheimer's patients with symptomatic behaviors compared to Alzheimer's disease patients without symptomatic behaviors.