CONTINUATION PHARMACOTHERAPY FOR AGITATION OF DEMENTIA

痴呆症躁动的持续药物治疗

• 批准号: 6629226
• 负责人: BRUCE G POLLOCK
• 金额: $ 29.09万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-03-15 至 2005-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6629226
• 关键词: Alzheimer's disease; antidepressants; antipsychotic agents; anxiety; behavior test; behavioral /social science research tag; clearance rate; clinical research; dementia; drug adverse effect; functional ability; gene frequency; hospital length of stay; human subject; human therapy evaluation; isozymes; mental disorder chemotherapy; mental health facility; outcomes research; relapse /recurrence; risperidone; serotonin inhibitor; serotonin receptor; serotonin transporter; therapy compliance

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.

描述（改编自申请人的摘要）：此的主要目标 修订应用程序（MH59666）“搅动的持续药物治疗 痴呆症”是进行比较为12周的双盲研究 高度选择性，5-羟色胺再摄取抑制剂的有效性， 西妥位酰胺和非典型抗精神病药，103例患者的dsperidone 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氏病及其Lewy的患者 最严重影响的身体变体：那些需要初始的人 BDAD的住院。医院BDAD的症状管理 在过去的五年中，大大改善了。不幸的是，缩短了长度 现在被要求留下 住院与功能更快的下降有关。我们的飞行员 数据表明，抗抑郁药对两者都非常有益 住院患者的精神病和非精神病性BDAD症状，至少在 短期。煽动和精神病症状的衰减 西妥位似乎等同于我们的 先前的治疗标准，常规的神经疗法，内嗪。这 perphenazine处理的患者的副作用负担增加为 然而，与西妥位和安慰剂组相反。 但是，这项功效研究是在高度控制的， 专门的住院环境，很短的时间（17天）。 此外，在社区实践中，rispeddone具有非典型的抗精神病药 成为BDAD的一线药物。解决持续的治疗 社区或疗养院（即在我们的学术环境之外） 已经建立了BDAD患者的治疗和评估系统 他们从医院出院。药物分配和剂量调整 将保持盲目，并将仔细监测患者。此外 对结局的临床和行为评估，拟议的研究也将 检查治疗反应是否与个体间 5-羟色胺转运蛋白5-羟色胺2N2C的等位基因变异 受体和CYP2D6药物代谢同工酶。药物血浆水平监测 将用于评估由于 合规性或药物清除的偏差。