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

点击翻译按钮获取中文摘要

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