Browsing by Author "Lungu, Codrin"

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    Parkinson's disease biomarkers: perspective from the NINDS Parkinson's Disease Biomarkers Program
    (Future Medicine, 2017-05) Gwinn, Katrina; David, Karen K.; Swanson-Fischer, Christine; Albin, Roger; St Hillaire-Clarke, Coryse; Sieber, Beth-Anne; Lungu, Codrin; Bowman, F. DuBois; Alcalay, Roy N.; Babcock, Debra; Dawson, Ted M.; Dewey, Richard B., Jr.; Foroud, Tatiana; German, Dwight; Huang, Xuemei; Petyuk, Vlad; Potashkin, Judith A.; Saunders-Pullman, Rachel; Sutherland, Margaret; Walt, David R.; West, Andrew B.; Zhang, Jing; Chen-Plotkin, Alice; Scherzer, Clemens R.; Vaillancourt, David E.; Rosenthal, Liana S.; Medical and Molecular Genetics, School of Medicine
    Biomarkers for Parkinson's disease (PD) diagnosis, prognostication and clinical trial cohort selection are an urgent need. While many promising markers have been discovered through the National Institute of Neurological Disorders and Stroke Parkinson's Disease Biomarker Program (PDBP) and other mechanisms, no single PD marker or set of markers are ready for clinical use. Here we discuss the current state of biomarker discovery for platforms relevant to PDBP. We discuss the role of the PDBP in PD biomarker identification and present guidelines to facilitate their development. These guidelines include: harmonizing procedures for biofluid acquisition and clinical assessments, replication of the most promising biomarkers, support and encouragement of publications that report negative findings, longitudinal follow-up of current cohorts including the PDBP, testing of wearable technologies to capture readouts between study visits and development of recently diagnosed (de novo) cohorts to foster identification of the earliest markers of disease onset.
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    Study in Parkinson's disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial
    (BMC, 2022-10-06) Patterson, Charity G.; Joslin, Elizabeth; Gil, Alexandra B.; Spigle, Wendy; Nemet, Todd; Chahine, Lana; Christiansen, Cory L.; Melanson, Ed; Kohrt, Wendy M.; Mancini, Martina; Josbeno, Deborah; Balfany, Katherine; Griffith, Garett; Dunlap, Mac Kenzie; Lamotte, Guillaume; Suttman, Erin; Larson, Danielle; Branson, Chantale; McKee, Kathleen E.; Goelz, Li; Poon, Cynthia; Tilley, Barbara; Kang, Un Jung; Tansey, Malú Gámez; Luthra, Nijee; Tanner, Caroline M.; Haus, Jacob M.; Fantuzzi, Giamila; McFarland, Nikolaus R.; Gonzalez-Latapi, Paulina; Foroud, Tatiana; Motl, Robert; Schwarzschild, Michael A.; Simuni, Tanya; Marek, Kenneth; Naito, Anna; Lungu, Codrin; Corcos, Daniel M.; SPARX3-PSG Investigators; Medical and Molecular Genetics, School of Medicine
    Background: To date, no medication has slowed the progression of Parkinson's disease (PD). Preclinical, epidemiological, and experimental data on humans all support many benefits of endurance exercise among persons with PD. The key question is whether there is a definitive additional benefit of exercising at high intensity, in terms of slowing disease progression, beyond the well-documented benefit of endurance training on a treadmill for fitness, gait, and functional mobility. This study will determine the efficacy of high-intensity endurance exercise as first-line therapy for persons diagnosed with PD within 3 years, and untreated with symptomatic therapy at baseline. Methods: This is a multicenter, randomized, evaluator-blinded study of endurance exercise training. The exercise intervention will be delivered by treadmill at 2 doses over 18 months: moderate intensity (4 days/week for 30 min per session at 60-65% maximum heart rate) and high intensity (4 days/week for 30 min per session at 80-85% maximum heart rate). We will randomize 370 participants and follow them at multiple time points for 24 months. The primary outcome is the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor score (Part III) with the primary analysis assessing the change in MDS-UPDRS motor score (Part III) over 12 months, or until initiation of symptomatic antiparkinsonian treatment if before 12 months. Secondary outcomes are striatal dopamine transporter binding, 6-min walk distance, number of daily steps, cognitive function, physical fitness, quality of life, time to initiate dopaminergic medication, circulating levels of C-reactive protein (CRP), and brain-derived neurotrophic factor (BDNF). Tertiary outcomes are walking stride length and turning velocity. Discussion: SPARX3 is a Phase 3 clinical trial designed to determine the efficacy of high-intensity, endurance treadmill exercise to slow the progression of PD as measured by the MDS-UPDRS motor score. Establishing whether high-intensity endurance treadmill exercise can slow the progression of PD would mark a significant breakthrough in treating PD. It would have a meaningful impact on the quality of life of people with PD, their caregivers and public health.