Clinical Operations and Procedures Core

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The goal of the Clinical Operations and Procedures Core (Clinical Core) of the Diabetes Prevention Program Outcomes Study (DPPOS) Alzheimer’s Disease (AD) and AD related dementias (ADRD) Project is to supervise training, certification, and quality control (QC) of the procedures and measures from the current phase of DPPOS, with the exception of legacy cognitive measures, that will be continued during DPPOS AD/ADRD. Cognitive procedures and measures are covered in the Cognitive Assessment and Adjudication Core (Cognition Core), and neuroimaging and AD/ADRD plasma biomarkers measures are covered in the Neuroimaging and Plasma Biomarkers Core (Biomarkers Core). The Clinical Core will facilitate and oversee all data collection procedures at the 25 clinical centers and support the DPPOS Central Biochemistry Laboratory (CBL) at the Advanced Research and Diagnostics Laboratory (ARDL, University of Minnesota), the electrocardiogram (ECG) Reading Center (Epidemiological Cardiology Research Center [EPICARE], Wake Forest University), and a vendor performing remote visits. The Clinical Core will follow the same rigorous procedures for staff training, and monitoring of clinical centers, the laboratory, the ECG reading center and the vendor performing remote participant visits as has successfully been done for the past 25 years in DPP/DPPOS. The long-term success of the DPPOS is due in large part to these longstanding operations, which will continue in the DPPOS AD/ADRD Project. The Clinical Core will achieve its goals through the following specific aims: (1) Provide oversight and management of all DPPOS clinical sites, including ensuring participant retention and timely completion of visits, monitoring completion and quality of participant study assessments and procedures, managing all study manuals and related documents; (2) Coordinate training and certification of clinical site staff in standardized measurements including physical function and activity, neuropathy, anthropometric measures and vital signs, cardiovascular and cerebrovascular disease outcomes, and collection of laboratory specimens; (3) Support the CBL at ARDL where biospecimens are shipped from the clinical centers, stored, and all core laboratory assays are measured, (except AD plasma biomarkers) , and biospecimens are shipped to Dr. Zetterberg at the University of Gothenburg to measure AD plasma biomarkers, and Dr. Kapogiannis at the National Institute on Aging for extraction of extracellular vesicles; (4) Support the ECG reading center at EPICARE, that will obtain participants’ hospitalization ECG recordings from study staff and provide ECG reading and interpretation to the Clinical Outcomes Adjudication team; (5) Support a Clinical Outcomes Adjudication committee that will adjudicate clinical outcomes and procure all available clinical brain imaging reports from participants; (6) Report clinically significant results to participants.