Core B: Clinical Core

ABSTRACT: CLINICAL CORE The mission of the University of Kansas (KU) ADRC's Clinical Core is to stimulate and support clinical and translational research in brain aging and Alzheimer's disease and related disorders (ADRD).

The Clinical Core serves as a hub supporting investigators with data, biological samples, research participants, and infrastructure to seed and support research endeavors, including cross-sectional, longitudinal, and investigator-initiated clinical trials. The Clinical Core also contributes to national research initiatives (NACC, NCRAD, ADNI, etc.).

The Clinical Core maintains a longitudinally characterized Clinical Cohort and has developed and evolved a responsive research infrastructure to support investigator-initiated and multi-site clinical studies.

The longitudinal Cohort stimulates and supports research by making participants, data, and biospecimens available to investigators.

In the last funding cycle, we supported 134 studies (from 82 investigators) with well- characterized participants (43 projects), biosamples (35 projects), retrospective data (21 projects), and research support drawing on our support infrastructure (35 projects).

Our support infrastructure includes a Clinical Trial Team, an Exercise Trial Team, and a Clinical Research Services Team (psychometric, safety, and clinical ratings) funded through P30 support and chargebacks for staff and services on investigator grants.

In the next funding cycle, we will continue to maintain the longitudinally characterized Clinical Cohort (n~400 actively followed participants) to support local and national studies (Aim 1).

Cohort participants are characterized annually (CDR and cognitive testing) and will complete lumbar puncture and brain MRI (for ATN biomarkers) and a neurovascular and blood-based metabolic biomarker profile to set the stage for vascular (V) and metabolic (M) biomarker development. We will continue to provide postmortem tissue to the Neuropathology Core through the Brain Autopsy Program.

We will also continue to support broad studies in aging and dementia and advance our understanding of the role of metabolism in aging and AD (Aim 2).

We have well developed systems for sharing highly characterized participants, data, and biospecimens with investigators (via the Data and Biomarker Cores).

Our infrastructure accelerates work on novel disease mechanisms including the role of energy metabolism in brain aging and AD.

We will continue to evolve our support structures to support NIH, industry, and investigator- initiated clinical trials, enabling bench-to-bedside testing of novel compounds and innovative non- pharmacological studies. The Clinical Core is central to the changing landscape of aging and ADRD research at KUMC.

We will strengthen and extend this foundation to provide an increasing number of investigators with the tools and resources they need to accelerate their work and encourage continued innovation in new avenues of research.