MPC-7869 MEASURE OF COGNITION, ACTIVITIES MILD DEMENTIA OF THE ALZHEIMER'S TYPE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项第三阶段的多国、随机、双盲、安慰剂对照研究，内容是MPC-7869(R-氟比洛芬，或称Flurizan)每日治疗对阿尔茨海默病类型轻度痴呆患者的认知、日常生活能力和全球功能的影响。主要目的是评估接受MPC-7869治疗的阿尔茨海默病患者的ADAS-COG和ADCS-ADL在认知和日常生活能力方面的变化。第二个目标是通过神经心理测试组合(NTB)来评估认知的变化，并以CDR-SB来评估全球功能的变化。探索性目标是通过生活质量-阿尔茨海默病量表(QOL-AD)和照顾者负担问卷来评估阿尔茨海默病患者及其照顾者生活质量的变化；使用痴呆症资源利用(RUD)精简问卷评估MPC-7869治疗对医疗资源使用和照顾者时间花费的影响。其他观察：使用MPC-7869治疗的安全性；脑脊液(可选)和外周血液分析潜在的生物标志物；MPC-7869的群体药代动力学。 这项平行分组研究将比较每天两次每天服用800毫克MPC-7869与安慰剂的安全性和有效性。研究对象将根据使用/不使用乙酰胆碱酯酶抑制剂和/或美金胺进行随机分层，并治疗18个月。本网站报名人数为30-40人。研究的总时间为每个参与者20个月。

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 Phase 3 Multinational, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment with MPC-7869 ( R-flurbiprofen, or Flurizan) on Measures of Cognition, Activities of Daily Living, and Global Function in Subjects with Mild Dementia of the Alzheimer's Type. The primary objective is to evaluate the change in cognition and activities of daily living, as measured by ADAS-cog, and ADCS-ADL in subjects with Alzheimer's disease treated with MPC-7869. The secondary objective is to assess changes in cognition as measured by a Neuropsychological Test Battery (NTB) and to assess changes in global function as measured CDR-sb. The exploratory objectives are to assess changes in quality of life of Alzheimer's disease patients and their caregivers as measured by the Quality of life -Alzheimer's Disease Scale (QOL-AD) and the Caregiver Burden Inventory; to assess the impact of treatment with MPC-7869 on healthcare resource use and caregiver time spent using the Resource Utilization In Dementia (RUD) Lite Questionnaire. Additional Observations: Safety of treatment with MPC-7869; Cerebrospinal fluid (optional) and peripheral blood analysis for potential biomarkers; Population pharmacokinetics of MPC-7869. This parallel group study will compare the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo.Study subjects will be stratified at randomization according to use/nonuse of acetylcholinesterase inhibitors and/or memantine, and treated for 18 months. The number of participants to be enrolled at this site is 30-40. The total duration of the study is 20 months per participant