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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项在阿尔茨海默型轻度痴呆受试者中评价MPC-7869（R-氟比洛芬或氟利赞）每日治疗对认知、日常生活活动和整体功能指标影响的III期多国、随机、双盲、安慰剂对照研究。主要目的是评价在用MPC-7869治疗的阿尔茨海默病受试者中认知和日常生活活动的变化，如通过ADAS-cog和ADCS-ADL测量的。次要目的是评估认知的变化，如通过神经心理测试组合（NTB）测量的，并评估整体功能的变化，如测量的CDR-sb。探索性目的是评估阿尔茨海默病患者及其照顾者的生活质量的变化，如通过生活质量-阿尔茨海默病量表（QOL-AD）和照顾者负担量表测量的;使用痴呆症资源利用（RUD）Lite问卷评估MPC-7869治疗对医疗保健资源使用和护理人员花费时间的影响。其他观察结果：MPC-7869治疗的安全性;脑脊液（可选）和外周血潜在生物标志物分析; MPC-7869的群体药代动力学。 该平行组研究将比较每日两次800 mg MPC-7869与安慰剂的安全性和有效性。研究受试者将根据使用/不使用乙酰胆碱酯酶抑制剂和/或美金刚进行随机分层，并治疗18个月。本研究中心入组的受试者人数为30-40人。每名参与者的研究总持续时间为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