AD

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• 批准号: 7951431
• 负责人: Thomas O Obisesan
• 金额: $ 0.48万
• 依托单位: HOWARD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951431
• 关键词: Address; Agitation; Attenuated; Behavior assessment; Chronic; Clinic Visits; Clinical; Clinical Research; Cognition; Cognitive; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Double-Blind Method; Funding; Grant; Institution; Measures; Nature; Onset of illness; Outpatients; Participant; Placebo Control; Population; Protocols documentation; Psychotic Disorders; Public Health; Randomized; Research; Research Personnel; Resources; Safety; Source; Telephone; United States National Institutes of Health; Universities; functional decline; valproate

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 randomized, placebo-controlled, double blind, multicenter, two-year trial of valproate therapy at a target dose of 10-12 mg/kg/d in 300 outpatients with mild to moderate AD who lack agitation and psychosis at baseline and since onset of illness. Participants will have regular clinic visits as well as telephone contacts for assessment of behaviour, cognition, function, safety and tolerability. Valproate was selected because of its possible symptomatic efficacy for agitation in AD, known safety profile in numerous clinical populations, and in view of recent data supporting its neuroprotective potential in AD. The primary hypothesis is that chronic valproate administration to participants with AD who lack agitation and psychosis at baseline will delay the emergence of agitation and/or psychosis. An effect of this nature may have significant public health implications, for instance, by delaying instutionalization. Secondary hypotheses will addressed as well. The first of these is that chronic valproate administration to participants with AD will attenuate clinical progression of illness measured by reduced rate of cognitive or functional decline. Participants will remain in the study and be followed per protocol for two years even if they discontinue experimental treatment prematurely, in order to examine possible effects on progression of cognitive or functional decline. In addition, the safety and tolerability of chronic low dose therapy will be addresed.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一个随机，安慰剂对照，双盲，多中心，两年的丙戊酸治疗试验，目标剂量为10-12 mg/kg/kg/kg/kg/kg/d，在300名门诊患者中，患有轻度至中度AD的门诊患者，他们在基线时缺乏躁动和精神病，并且自疾病发作以来。参与者将定期进行诊所访问和电话联系，以评估行为，认知，功能，安全性和容忍度。之所以选择丙戊酸，是因为其可能有症状的AD搅动功效，众多临床人群中已知的安全性，并且鉴于最近支持其神经保护潜力的数据。主要的假设是，在基线时缺乏躁动和精神病的参与者慢性丙丙酸酯给药将延迟搅动和/或精神病的出现。这种性质的影响可能具有延迟机构化的重要公共卫生影响。 次要假设也将解决。首先是，慢性丙丙酸酯对AD参与者的施用将减少通过降低认知或功能下降率降低的疾病临床进展。参与者将保留在研究中，并按照协议进行两年的遵守，即使他们过早地停止实验治疗，以便检查对认知或功能下降进展的可能影响。另外，将增加慢性低剂量疗法的安全性和耐受性。