CONTINUATION PHARMACOTHERAPY FOR AGITATION OF DEMENTIA

描述（改编自申请人的摘要）：本发明的主要目标是： 修订申请（MH 59666）“持续药物治疗躁动 痴呆症”是进行为期12周的双盲研究， 高选择性血清素再摄取抑制剂的有效性， 西酞普兰和非典型抗精神病药dsperidone在103例患者中 患有与阿尔茨海默氏痴呆症相关的行为障碍 （BDAD）。这项研究的重点是阿尔茨海默病患者及其路易 受影响最严重的身体变异：那些需要初始 因BDAD住院治疗。医院BDAD的症状管理 在过去的五年里有了很大的改善。不幸的是， 现在强制要求延期，且BDAD很有可能再次发生 住院治疗与更快的功能衰退有关。我们的飞行员 数据表明，抗抑郁药西酞普兰对这两种疾病都有好处。 住院患者的精神病性和非精神病性BDAD症状，至少在 短期的通过以下方式减轻激越和精神病症状 西酞普兰似乎与我们的 治疗前标准，常规抗精神病药，奋乃静。的 奋乃静治疗患者的副作用负担增加， 然而，与西酞普兰和安慰剂组相比，这是显著的。 尽管如此，这项疗效研究是在高度对照的， 专业的住院环境，非常短的时间（17天）。 此外，在社区实践中，非典型抗精神病药Rispeddone 成为BDAD的一线药物。为了解决继续治疗的问题， 社区或疗养院（即，我们的学术环境之外），我们 已经建立了BDAD患者的治疗和评估系统， 他们出院了药物分配和剂量调整 将保持盲态，并对患者进行仔细监测。除了 临床和行为评估的结果，拟议的研究还将 检查治疗反应是否与个体间 5-羟色胺转运蛋白启动子2N 2C的等位基因变异 受体和CYP 2D 6药物代谢同工酶。血浆药物浓度监测 将用于评估药物暴露差异的影响， 依从性或药物清除的偏差。

DESCRIPTION (Adapted from the Applicant's Abstract): The primary goal of this revised application (MH59666) "Continuation Pharmacotherapy for Agitation of Dementia" is to conduct a 12-week, double-blind study of the comparative effectiveness of the highly selective, serotonin reuptake inhibitor, citalopram, and the atypical antipsychotic, dsperidone in 103 patients suffering from behavioral disturbances associated with Alzheimer's dementia (BDAD). This study focuses on patients with Alzheimer's disease and its Lewy body variant who are most severely affected: those who have required initial hospitalization for BDAD. Symptomatic management of BDAD in the hospital has greatly improved over the past five years. Unfortunately, shortened lengths of stay are now mandated and BDAD has a high likelihood to recur and repeated hospitalizations are associated with more rapid functional decline. Our pilot data suggest that the antidepressant citalopram is acutely beneficial for both psychotic and non-psychotic BDAD symptoms in hospitalized patients, at least in the short-term. Attenuation of agitation and psychotic symptoms achieved with citalopram appeared to be equivalent to, or better than that achieved with our prior treatment standard, the conventional neuroleptic, perphenazine. The increase in side effect burden for the perphenazine-treated patients was significant, however, in contrast to the citalopram and placebo groups. Nonetheless, this efficacy study was conducted in a highly controlled, specialized, inpatient environment, for a very brief period of time (17 days). Moreover, in community-practice, the atypical antipsychotic, rispeddone has become a first-line medication for BDAD. To address continuing treatment in the community or in the nursing home (i.e., outside of our academic setting) we have established a system of treatment and assessment for BDAD patients upon their discharge from the hospital. Medication assignment and dosage adjustments will remain blinded and patients will be carefully monitored. In addition to clinical and behavioral assessments of outcomes, the proposed study will also examine whether therapeutic response is associated with inter-individual allelic variations in the serotonin transporter promoter, serotonin 2N2C receptors, and CYP2D6 drug metabolizing isoenzyme. Drug plasma level monitoring will be utilized to assess the impact of variance in drug exposure due to deviations in compliance or drug clearance.