The Clinical Core serves as the central source of research subjects for the ADC. Its primary function is to provide ADC associated research projects and pilot studies with well-diagnosed subjects and with clinical materials (e.g., blood, CSF, etc.). The Clinical Core includes a Satellite Multicultural Program (SMP), which focuses on minority recruitment. The Core population currently includes more than 4,900 cases consisting of patients with AD, other dementias, and mild cognitive impairment, as well as normal adult subjects. About 150 to 200 new subjects have been added to the Core annually. The population is reassessed longitudinally and tracked to autopsy. All data are included in a central database maintained by the Data Management Core. During the past five years the Clinical Core has more than achieved its specific aims. From 1/1/2005 to 3/20/2009, 732 new patients and 1,797 follow-up evaluations were completed. Since October, 2005, National Alzheimer's Coordinating Center (NACC) Uniform Data Set (UDS) measures have been completed in Clinical Core subjects resulting in the largest UDS population of any ADC, comprising 1,167 subjects on whom 708 follow-ups have been conducted. Most Core subjects participate in various research protocols. Since 2005, more than 38 separate federally funded research grants have utilized Clinical Core resources. The Core helps support a Clinical Trials Unit which participates in the multicenter NIA-Alzheimer's Disease Cooperative Study (ADCS) and since 2005, the Core has participated in 26 NIH ADCS and industry sponsored pharmacologic trials. The Core also maintains a CSF bank and a serum/DNA bank and has close interactions with all of the other ADC Cores. With renewal, we propose to continue to focus the Clinical Core on the transition between normal cognition and mild cognitive impairments. We will continue to follow-up enrolled patients. Such an effort will support our current portfolio of NIH grants, NIH NACC UDS subject contributions, ADCS studies and medication trials, as well as other collaborations and studies, and enable us to target therapeutic prevention trials.
Research associated with the Clinical Core has resulted in new and current FDA approved medications for AD treatment. Resources produced by the Clinical Core are used to better understand and assess AD worldwide, and as research tools. Clinical Core associated research is now focusing on the prevention of AD in normal older persons, in part using Core developed resources.
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