COMMERCIAL ORGANIZATIONS GRANTS

  • A multinational, multicenter, randomized, Phase III parallel group, placebo controlled study performed in subjects with Relapsing Remitting Multiple Sclerosis (RRMS) to assess efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered every four weeks.
    Role: R. Zivadinov, PI for MRI; (PI: Aron Miller, MD)
    Agency: Mapi Pharma
    Aim: To assess efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate administered every four weeks, as compared to placebo in a double blind study design of 52 weeks duration. To assess the long-term safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered every four weeks, in subjects treated for up to 104 weeks with GA Depot.
    Period: October 2017 – October 2021
  • Multicenter integration of real-world brain volume and lesion assessment in adult and pediatric multiple sclerosis.
    Role: Michael G Dwyer, PI; R. Zivadinov, Co-PI
    Agency: Novartis
    Aim: To validate a measure of overall brain status, as determined by a composite of lateral ventricle volume (LVV) and salient central lesion volume (SCLV) in adult and pediatric MS population, using real-world multicenter datasets.
    Period: October 2017 – October 2018
  • A prospective, multicenter, single arm, open label, phase IIa study to assess the safety and efficacy of once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot) in subjects with Primary Progressive Multiple Sclerosis (PPMS).
    Role: R. Zivadinov, PI for MRI
    Agency: Mapi Pharma
    Aim: To assess the safety and efficacy of GA Depot to slow the accumulation of disability progression in subjects with primary-progressive MS.
    Period: October 2017 – October 2021
  • Cerebral protection in transcatheter aortic valve replacement: the PROTEMBO SF trial.
    Role: R. Zivadinov, PI for MRI
    Agency: Protembis
    Aim: The objective of the study is to assess the safety and feasibility of the ProtEmbo System used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
    Period: June 2017 – December 2018
  • Effect of Anti-CD20 on MOG EAE mouse model of multiple sclerosis.
    Role: R. Zivadinov, PI
    Agency: Novartis
    Aim: The primary aim of this study is to investigate the effect of mouse anti-CD20 antibody (anti-CD20) on brain and spinal cord tissue pathology progression in the myelin oligodendrocyte human protein (MOG) experimental autoimmune encephalomyelitis (EAE) mouse model of multiple sclerosis (MS) by use of brain and spinal cord magnetic resonance imaging (MRI).
    Period: June 2017 – December 2018
  • Effect of anti-muCD52 antibody on brain and spinal cord imaging markers of neurodegeneration, microglia, and macrophage activation in the Theiler’s Murine Encephalomyelitis Virus model of demyelination.
    Role: R. Zivadinov, PI
    Agency: Genzyme
    Aim: The primary aim of this study is to investigate the effect of anti-CD52 antibody to mouse (anti-muCD52) on brain and spinal cord imaging markers of neurodegeneration in the Theiler’s Murine Encephalomyelitis Virus (TMEV) mouse model of chronic demyelination by use of magnetic resonance imaging (MRI).
    Period: June 2017 – December 2018
  • Effect of Ocrelizumab on cognitive dysfunction and gray matter pathology in multiple sclerosis
    Role: R. Zivadinov, PI
    Agency: Genentech
    Aim: The primary objectives of the trial are to explore the efficacy of ocrelizumab in reducing gray matter (GM) pathology and leptomeningeal inflammation over 24 months.The secondary objective of the trial is to assess the efficacy of ocrelizumab in preservation of cognitive function in multiple sclerosis (MS) patients over 24 months.
    Period: April 2017 – April 2020
  • Retrospective Analysis on Data from a Real-World MS Clinical Network (RADAR).
    Role: R. Zivadinov, PI
    Agency: Genzyme
    Aim: The primary objective (endpoint) of this study is to measure the proportion of patients with new and enlarging T2-weighted or Gadolinium-enhanced (Gd) lesions among RMS patients treated with Aubagio® (teriflunomide) or Tecfidera® (dimethyl fumarate).
    Period: May 2016 – December 2017
  • Effect of teriflunomide (Aubagio®) on gray and white matter pathology in multiple sclerosis using tract-based spatial statistics (TBSS). A retrospective study
    Role: R. Zivadinov, PI
    Agency: Genzyme
    Aim: The primary aim of this sub-study is to define the effect of teriflunomide on gray matter (GM) pathology, as measured by changes in diffusion-tensor imaging (DTI) of the thalamus in patients with relapsing MS.
    Period: November 2016 – October 2017
  • Aging and disability progression in multiple sclerosis
    Role: R. Zivadinov, Co-investigator, (PI: Bianca Weinstock-Guttman, MD)
    Agency: Biogen Idec.
    Aim: Role of clinical, neurological, socio-economic characteristics associated with disease progression in patients ≥ 60 years old. To identify multifactorial predictors of major disability and of rate of disability deterioration, such as: patient employment, sex, race, educational attainment, living environment (self-care, caretaker or institutional such as nursing home), DMT use, and insurance status.
    Period: December 2015 – December 2018
  • Creation of a multi-center database to study real world brain volume changes in multiple sclerosis (MS).
    Role: R. Zivadinov, PI
    Agency: Novartis, Inc.
    Aim: We propose to validate and deploy NeuroSTREAM as an iPad/tablet/PC application to simplify the calculation of standardizable brain atrophy measures in clinical routine and allow academic and community neurologists to plan, perform, and publish novel and influential clinical research using data from clinical routine.
    Period: December 2015 – December 2017
  • NeuroSTREAM – Neurological Software Tool for REliable Atrophy Measurement – Technical improvements and clinical validation in large cohort of patients with multiple sclerosis.
    Role: R. Zivadinov, Co-PI (PI: Michael G. Dwyer, PhD)
    Agency: Novartis, Inc.
    Aim: The goal of this study is to make the NeuroSTREAM method more general by extending it to other clinical scan types (3D T1 and 2D T1-SE) and to direct longitudinal measurement. Second, we will add clinical context to brain atrophy measures by providing normative data from large cohort of 400 healthy controls and 3,000 MS subjects followed over a decade at the Department of Neurology at the University at Buffalo. We will also use this data to generate and validate predictive models relating cross-sectional and longitudinal atrophy to disease outcomes.
    Period: December 2015 – December 2017
  • MRI services for complete cerebral protection of acute embolic burden during transcatheter aortic valve implantation – a randomized diffusion-weighted MRI study – (The Sentinel-L study).
    Role: R. Zivadinov, PI for MRI
    Agency: Claret Medical, Inc.
    Aim: To study the effect of the use of the LV 1 System with the Sentinel System, during TAVR, with respect to procedure-related cerebral embolic burden in patients assessed by DW-MRI. To limit data variability and avoid confounding effects of different TAVI devices, patients enrolled will be those expected to receive only one type of TAVI device (Boston Scientific Lotus Valve System, a next generation repositionable device).
    Period: June 2015 – December 2017
  • Creation of a multi-center database to study real world brain changes and patient outcomes in multiple sclerosis (MS) patients on fingolimod.
    Role: R. Zivadinov, PI
    Agency: Novartis
    Aim: To describe whether retrospective, multi center collection of MRI scan data collected in real world clinical practice can be utilized to observe changes in brain volume and brain lesion number among patients initiated on fingolimod.
    Period: October 2014 – December 2017
  • Teriflunomide (Aubagio®) effects on cognitive and vocational outcomes, as related to neurodegeneration in multiple sclerosis: A prospective, observational, single-blinded study.
    Role: R. Zivadinov, Co-investigator, (PI: Ralph Benedict, PhD).
    Agency: Genzyme Inc.
    Aim: The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on cognitive abilities in patients with relapsing multiple sclerosis (MS). There are two secondary objectives, to [a] relate changes in cognition to vocational problems, and [b] determine MRI correlates of change in cognition, more specifically gray-matter (GM) volume metrics which we believe reflect neurodegeneration.
    Period: January 2014 – December 2017
  • Effect of teriflunomide (Aubagio®) on cortico-basal ganglionic-thalamo-cortical gray matter connectivity in the Theiler’s Murine Encephalomyelitis Virus model of demyelination.
    Role: R. Zivadinov, PI
    Agency: Genzyme Inc.
    Aim: The primary aim of this study is to investigate the effect of teriflunomide (Aubagio) on
    the cortex, basal ganglia, and thalamus (CxBGTh) tissue pathology progression in the Theiler’s Murine Encephalomyelitis Virus (TMEV) mouse model of chronic demyelination by use of magnetic resonance imaging (MRI). The secondary aim of this study is to explore the effect of Aubagio on various markers of chronic demyelination in the TMEV brain through biochemical analysis.
    Period: December 2014 – December 2017
  • Open-label, single-blinded, observational, prospective, 24-months, longitudinal, controlled study to assess the efficacy of fingolimod (Gilenya®) on development of thalamus pathology and cognitive impairment in patients with relapsing forms of multiple sclerosis.
    Role: R. Zivadinov, PI
    Agency: Novartis, Inc.
    Aim: To assess the effect of the Gilenya over 6, 12 and 24 months on the evolution of thalamic atrophy in patients with relapsing MS, as measured by change in thalamic volume loss. The changes in thalamic volume over the same time period in HC will be used as a reference.
    Period: June 2013 –December 2017
  • Research collaboration agreement among Buffalo Neuroimaging Analysis Center, General Electric Company, The State University of New York at Buffalo, Kaleida Health Systems and University Neurology, Inc.
    Role:
    R Zivadinov, PI
    Agency: General Electric Company
    Aim: The research objectives of this research program are to investigate and develop MR, its applications and technology using GE’s MR Systems.
    Period: June 2006 – December 2020