COMMERCIAL ORGANIZATIONS GRANTS

  • 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
  • An open-label, prospective, observational, single-blinded, longitudinal study to evaluate the effect of dimethyl fumarate on gray and white matter pathology in subjects with relapsing multiple sclerosis.
    Role: R. Zivadinov, PI
    Agency: Biogen Idec, Inc.
    Aim: The primary aim of this study is to explore the effect of dimethyl fumarate (Tecfidera®) on gray matter (GM) pathology, as measured by changes in diffusion-tensor imaging (DTI) of the thalamus in patients with relapsing multiple sclerosis (MS). The secondary objective of this study is to investigate the effect of dimethyl fumarate on evolution of microstructural changes in normal appearing white matter (NAWM), as measured by DTI.
    Period: November 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 2016
  • 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: IMS Health
    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 2016
  • Effect of 2.5 years of rasagiline therapy on progression of cognitive biomarkers assessed by MRI in Parkinson’s disease.
    Role: R. Zivadinov, Co-PI, (PI: Thomas Guttuso, MD)
    Agency: Teva Pharmaceuticals
    Aim: To compare the changes in brain cognitive biomarkers over 2.5 years among Idiopathic Parkinson’s disease patients receiving rasagiline (IPD-R), IPD patients not receiving MAO-B inhibitors (IPD-NM) and healthy controls (HC).
    Period: January2014 – December 2016
  • 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 2016
  • MRI services for double-blind, randomized, parallel-group, multicenter study comparing safety and efficacy of monotherapy with INT131 1 mg or 3 mg administered orally or placebo once daily in treatment naïve patients with relapsing/remitting multiple sclerosis.
    Role: R. Zivadinov, PI for MRI (PI: David Weinstein, MD, PhD)
    Agency: Intektin Therapeutics Inc
    Aim: To evaluate in a blinded manner de-identified scans from 210 MS subjects mnotherapy with INT131 1 mg or 3 mg administered orally or placebo once daily in treatment naïve patients with relapsing-remitting multiple sclerosis.
    Period: May 2014 – December 2016
  • MRI services for Cerebral Protection in Transcatheter Aortic Valve Replacement –(The SENTINEL) study.
    Role: R. Zivadinov, PI
    Agency: Claret Medical, Inc
    Aim: The objective of this study is to assess the safety and efficacy of the Claret Medical Sentinel Cerebral Protection System used for embolic protection during transcatheter aortic valve replacement (TAVR) compared to TAVR standard of care (without embolic protection).
    Period: April 2014 – December 2016
  • An open-label, prospective, observational, single-blinded, longitudinal, cross-over study to evaluate the effect of switching from daily injections of 20mg glatiramer acetate (GA) to 40mg GA three times a week on thalamic pathology in subjects with relapsing-remitting multiple sclerosis
    Role: R. Zivadinov, PI
    Agency: TEVA Pharmaceuticals, Inc.
    Aim: The primary aim of this study is to explore the effect of switching from daily injections of 20mg glatiramer acetate (GA) (20mg/daily) to GA 40mg three times a week (40mg x 3/weekly) on thalamus pathology, as measured by changes in diffusion-tensor imaging (DTI) in patients with relapsing-remitting multiple sclerosis (RRMS).
    Period: June 2013 –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
  • Effect of teriflunomide (Aubagio®) on gray matter pathology in multiple sclerosis;  The 12 months, prospective, observational, single-blinded, longitudinal study.
    Role: R. Zivadinov, PI
    Agency:Gemzyme, Inc.
    Aim: The primary aim of this study is to define the effect of teriflunomide  (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS). The secondary objective of this study is to define the effect of the teriflunomide on subcortical deep gray matter (SDGM) pathology over 12 months.
    Period: June 2013 –December 2016
  • Defining the hierarchy of the anatomic, physiologic, and metabolic neuro-degenerative changes in optic neuritis and multiple sclerosis.
    Role: R. Zivadinov, PI for MRI, (PI: Robert C. Sergott, MD).
    Agency:Neuro-Ophthalmologic Associates, PC.
    Aim: The aims of the study are to: 1) use the baseline retinal changes as the index for association with various MS phenotype; 2) to correlate retinal biomarkers to volumetric MRI outcomes; and 3) to characterize functional deficits analyzed for amplitude and latency with the electro-physiological results correlated to the thickness measurements of each retinal layer as assessed by special auto-segmentation software.
    Period: December 2013 – December 2016
  • 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 2016