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Projects Portfolio

Current Projects

MEDFocus
NeuroNEXT
Champ Study
The Parkinson's Progression Markers Initiative (PPMI)
Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION)
Clinical Islet Transplantation (CIT) Consortium

MEDFocus
This is a multi-center, cluster-randomized study utilizing a centralized cardiovascular risk service (CVRS) in medicial offices with large geographic, racial and ethnic diversity to determine the extent to which the CVRS model will be implemented. Sixteen primary care offices will be randomized to the CVRS or usual care and 400 subjects will be enrolled, 240 of which will be from racial minorities. The central hypothesis of this study is that a centralized CVRS managed by clinical pharmacists will be implemented and significantly improve CVD guideline adherence using the Guideline Advantage metrics. The rational for this study is that implementation of a novel strategy to improve secondary prevention of CVD will lead to innovative strategies for broader adoption by health systems throughout the United States. The CTSDMC is the data coordinating center for this study, and supports data collection, data management, clinical site support and monitoring, and statistical analyses.

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NeuroNEXT
The long-term objective of the Network of Excellence in Neuroscience Clinical Trials (NEXT) initiative is to rapidly and efficiently translate advances in neuroscience into treatments for people with neurological disorders. Acute and chronic neurological disorders impose a massive burden on both patients and society. The potential exists to change this situation if recent major discoveries in basic neuroscience can be exploited effectively. Challenges to the successful and efficient development of treatments for people with neurological disorders include inefficiencies in regulatory and institutional submissions and approvals, a variety of barriers to recruitment of subjects that slow down clinical research and a shortage of individuals trained and prepared to lead multicenter trials.

The NeuroNEXT program aims to:

  • Provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. The network includes multiple Clinical Sites, one Clinical Coordinating Center (CCC) and one Data Coordinating Center (DCC).
  • Support scientifically sound, possibly biomarker-informed, Phase II clinical trials that provide data for clear go/no-go decisions.
  • Energize and mobilize federal, industry, foundations and patient advocacy partners by leveraging existing relationships between NINDS and NeuroNEXT to organize high impact Phase II clinical trials for neurological disorders.
  • Expand the pool of experienced clinical investigators and research staff who are prepared to be leaders of multicenter clinical research trials.
  • Working with NeuroNEXT is a cooperative venture between NINDS, the NeuroNEXT network and the applicant.
      

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Champ Study
The global objective is to determine the optimal medication for the prevention of migraines in children and adolescents, with the primary objective being to test whether amitriptyline (AMI) and topiramate (TPM) are superior to placebo in reducing migraine frequency in children and adolescents, ages 8 to 17 years old, inclusive, and to conduct a comparative effectiveness study of the two therapies.

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The Parkinson's Progression Markers Initiative (PPMI)
The CTSDMC currently serves as the statistics core for the Parkinson's Progression Marker's Initiatve (PPMI). PPMI is a landmark observational clinical study to comprehensively evaluate a cohort of recently diagnosed PD patients and healthy subjects using advanced imaging, biologics sampling, and clinical and behavioral assessments to identify biomarkers of Parkinson's disease progression. PPMI will be carried out over five years at 18 clinical sites in the United States and Europe and requires the participation of 400 Parkinson's patients and 200 control participants. Data and samples acquired from study participants will enable the development of a comprehensive Parkinson's database and biorepository, which will be available to the scientific community to conduct field-changing research. PPMI is made possible by the concerted efforts of a number of collaborators. This study is being sponsored by the Michael J. Fox Foundation for Parkinson's Research.

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Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION)
Blood pressure (BP) is controlled in only 34% of patients with high BP, leading to unnecessary strokes, myocardial infarctions and other cardiovascular events. BP control can be improved with physician/pharmacist collaborative management (PPCM). Our long-range goal is to achieve excellent BP control rates using PPCM that can be implemented in private practices in diverse communities. Our model achieved 89% BP control in an efficacy trial and suggests that PPCM might overcome typical racial and socioeconomic barriers. The objective is to conduct a large multi-center clinical trial in clinics with geographic, racial and ethnic diversity to determine the extent to which the model is implemented. This practice-based research network (PBRN) is unique with a large minority population and great diversity in operation and community size.

This prospective, cluster-randomized trial uses 27 clinics, matched and randomized to the active intervention (2 groups) or a control group. Following 9 months of the intervention, one group will continue the intervention following 9 months while the other will discontinue it. We will also randomize 18 patients per clinic into a passive observation group (n=486) to determine if PPCM is implemented more broadly in the clinic. Patients in all three groups will be followed for 24 months. Our innovative approach addresses critical organizational barriers and challenges existing approaches to achieving better BP control. We expect that our study will find a 6-8mm Hg difference in systolic BP which would lead to 20-30% fewer coronary deaths and 25-40% fewer stroke deaths if applied across broadly across similar settings.

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Clinical Islet Transplantation (CIT) Consortium

Type-1 Diabetes Clinical Trial Background
Insulin-dependent diabetes mellitus, or Type-1 diabetes (T1D) is an autoimmune disease characterized by the destruction of the insulin-secreting beta cells of the pancreas. T1D is difficult to control with the current therapies available, and as a result patients may suffer devastating consequences including accelerated cardiovascular and peripheral vascular diseases, nephropathy, retinopathy, neuropathy, oral diseases and premature death. The incidence of T1D appears to be increasing worldwide. Islet transplantation as a therapy for T1D has been an important focus of governmental funding, and significant research progress has occurred in recent years. Islet transplantation is a procedure performed on select patients with Type-1 diabetes to replace insulin-producing cells destroyed by the disease and restore normal blood sugar levels. In particular, the success of the "Edmonton Protocol" for islet transplantation in freeing individuals with T1D from the need for insulin therapy has established islet transplantation as a realistic therapy for those T1D patients whose disease cannot be effectively managed with current methods of insulin administration.

Clinical Islet Transplantation Trial
This islet transplantation trial, supported by the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID), and Juvenile Diabetes Research Foundation (JDRF), will continue fostering development of islet transplantation as a cure for T1D. Selected patients with Type-I diabetes who have received a successful kidney transplant may be excellent candidates for islet transplantation. It is the aim of this new trial to improve methods of isolating islets, to improve techniques for the administering those transplanted islets; and to develop approaches to minimize the toxic effects of immunosuppressive drugs required for transplantation.

The CITC studies focus on improving the safety and long-term success of transplanting islets (the insulin-producing cells of the pancreas) in people whose own islets have been destroyed by the autoimmune process that characterizes type 1 diabetes. Some studies focus on improving combined islet and kidney transplants in patients with type 1 diabetes and kidney failure, a common complication of diabetes.

CITC studies will focus on:

  • improving the isolation and viability of islets
  • reducing complications of the islet transplant procedure (e.g., bleeding and clotting in the blood vessels of the liver)
  • reducing the side effects of immunosuppression
  • achieving good blood sugar control without hypoglycemia
  • following the fate of islets after transplantation and determining why donor islets sometimes fail
  • evaluating new ways to safely prevent immune rejection of donor tissues
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