Clinical Core

ABSTRACT: CLINICAL CORE The Clinical Core (CC) supports ongoing and planned research programs at UAB, contributing to national Alzheimer’s disease and related dementias (ADRD) research efforts. The CC focuses on clinical assessments to support better understanding of ADRD risk factors especially prevalent in the Deep South. The CC has three main products: (1) well-characterized participants referred to researchers in the ADRC including to the Imaging Core and pre-consented autopsy cases for the Neuropathology Core, as well as the UAB and national ADRD communities, (2) biofluid samples for genetic analysis and banking in the Neuropathology Core for sharing with investigators, and (3) longitudinal clinical and functional outcome data to be made available through the Data Management and Statistical (DMS) Core and the National Alzheimer’s Coordinating Center (NACC). Projected enrollment will be ~525 new participants, with ~105 participants entering annually for each of the 5 years. Cognitively unimpaired (N ~263), Mild Cognitive Impairment (N ~158) and mild dementia (N ~104) participants will be preferentially engaged from community, rather than clinical, settings and followed annually. To accelerate studies of health disparities in ADRD, Black or African American (B/AA) participants will be enrolled at a proportion higher their frequency in the population of Alabama (≥40% vs. 23%). The NACC Uniform Data Set, additional cognitive testing, assessments of social determinants of health (SDOH), body composition, and actigraphic measures of activity will be collected, along with blood, CSF, and urine samples. Genotyping from blood will be conducted and shared via NIAGADS. Biofluids will be aliquoted and stored for local researcher access and sharing via NCRAD. All eligible subjects will be referred to the Imaging Core for structural and molecular imaging (MRI, amyloid-PET, and tau-PET). A multidisciplinary Clinical Consensus Conference determines clinical diagnoses. An innovative Biomarker Consensus Conference classifies individuals’ ATN biomarker status while blinded to the clinical data and diagnoses. The CC will interact with all other UAB ADRC Cores. It will function under the directives of the Administrative Core which oversees participant referrals via the ADRC’s Protocol Review process. Retention of participants is done cooperatively with the Outreach, Recruitment, and Engagement Core. CC data will be managed by the DMS Core, which in turn provides formatted data summaries to the CC for Consensus diagnosis. Autopsy coordination and pre-consent are managed by the CC on behalf of the Neuropathology Core’s Brain Donation Program. CC activities provide training opportunities for Research Education Component learners.