Resource Core 2 (RC2), Clinical Research

PROJECT SUMMARY – RESOURCE CORE 2 (RC2), CLINICAL RESEARCH CORE The Clinical Research Core (RC2) will play a central role in the Los Angeles Claude D. Pepper Older Americans Independence Center (LA OAIC) by facilitating the translation of discoveries in the biology of aging from the laboratory bench to the clinical arena. RC2 is a comprehensive clinical trials program that will provide the knowledge, skills, and technical support to conduct global evaluations of rigorously-designed gerotherapeutic clinical interventions to extend healthspan and treat aging-induced diseases. RC2 will expand the scope of translational geroscience by promoting clinical trials across the clinical development spectrum, from proof-of-concept to multi-center clinical trials. It will provide centralized, clinical trial support for study design, regulatory requirements, recruitment and retention, assessments, procedures, and data management. The Specific Aims of RC2 are to: Aim 1) Provide expertise to investigators for the planning of innovative studies to study human aging biology and rigorously evaluate interventions for healthspan extension; Aim 2) Provide clinical research infrastructure to ensure successful participant recruitment and safe and ethical conduct of all LA OAIC-supported clinical studies; Aim 3) Promote the conduct of geroscience-guided multicenter Phase 2 and Phase 3 clinical trials; and Aim 4) Provide translational geroscience training to early-stage scientists and those new to clinical research. To facilitate studies of the impact of potential gerotherapeutics on healthspan-related parameters, RC2 will assist investigators by performing comprehensive functional assessments. RC2 will collect biospecimens (blood, muscle, adipose, skin, urine, cerebrospinal fluid, microbiome) for studies of cellular aging, target engagement, measurements of drug/compound levels, and biomarkers. Also, RC2 will leverage and augment a recently created longitudinal cohort study of participants (Los Angeles Cohort on Aging [LACA]) that will serve as a resource of biological, clinical, and phenotypic data for translational geroscience studies in humans. In the first year of the next award period, RC2 plans to support 4 pilot (PES), 3 Scholar (REC) and 12 external projects (EPs). Additionally, RC2 will support 2 highly innovative developmental projects (DPs). • DP-3 will leverage a novel NIA-funded trial on metformin vs. placebo for frailty prevention in older adults to test and compare the performance of several omic-based biological clocks and determine their potential to predict changes in healthspan phenotypes and clinically-relevant, actionable outcomes. • DP-4 will use cells from the LACA cohort to develop subject-cell specific and human induced pluripotent stem cell-based models for drug screening and target identification for gerotherapeutic development. We anticipate that by the end of the funding period, RC2, in conjunction with the LA OAIC and external colleagues, will have identified novel interventions with potential to extend healthy longevity in people.