COMMERCIAL ORGANIZATIONS GRANTS

  • 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 2016
  • MRI analysis of the brain damage occurring with the use of a cerebral protection system in patients undergoing trans-femoral aortic valve implantation.
    Role: R. Zivadinov, PI for MRI, (PI: Axel Link, MD).
    Agency: Claret Medical, Inc.
    Aim: To assess the effect of Claret MontageTM Dual Filter System on prevention of cerebral ischemia in patients who received transfemoral percutaneous valve replacement.
    Period: November 2013 – December 2015
  • 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 2015
  • 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 2015
  • A prospective, observational, single-blinded, longitudinal optical coherence tomography study of the effect of glatiramer acetate on retinal nerve fiber layer thickness in patients with relapsing-remitting multiple sclerosis over 24 months.
    Role: R. Zivadinov, PI
    Agency:TEVA Pharmaceuticals, Inc.
    Aim: To assess the effect of the glatiramer acetate on optical coherence tomography, using retinal nerve fiber layer thickness, in patients with relapsing-remitting multiple sclerosis over 24 months.The changes in healthy controls will be used as a reference.
    Period: December 2013 – December 2015
  • A 36 months extension of multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg/ml administered three times a week or once weekly compared to placebo in a double-blind design.
    Role: R. Zivadinov, PI for MRI
    Agency: Teva Pharmaceuticals, Inc.
    Aim: To assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg/ml administered three times a week or once weekly compared to placebo in a double-blind study design extended to open label follow-up over 36 months.
    Period: March 2013 –December 2014
  • A prospective, observational, single-blinded, longitudinal MRI study of effect of glatiramer acetate on iron deposition in patients with relapsing-remitting multiple sclerosis over 24 months.
    Role: R. Zivadinov, PI
    Agency: Teva Pharmaceuticals, Inc.
    Aim: To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls. To investigate whether treatment with GA may decrease accumulation of iron in lesions, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months.
    Period: June 2012 –December 2014
  • Open-label, single-blinded, observational, prospective, 1-year follow-up, controlled study to assess the efficacy of fingolimod (Gilenya®) on remyelination and demelynation in patients with relapsing forms of multiple sclerosis.
    Role: R. Zivadinov, PI
    Agency: Novartis, Inc.
    Aim: The primary objective of this study is to assess the effect of the Gilenya over 1-year on the evolution of remyelination (as indicated by volume within NABT undergoing increases in VWMTR) and demyelination (as indicated by volume within NABT undergoing decreases of VWMTR) in patients with relapsing MS.
    Period: May 2012 –December 2015
  • A prospective,  observational, single-blinded, longitudinal study of natalizumab effect on brain atrophy and disability in multiple sclerosis patients over 5 years.
    Role: R. Zivadinov, PI
    Agency: Biogen Idec, Inc.
    Aim: To define the effect of the number of natalizumab cycles on development of brain atrophy and progression of disability in originally treated patients with natalizumab in relapsing multiple sclerosis.
    Period: May 2012 –December 2014
  • Natalizumab Temporary Discontinuation Study (NaTDS).
    Role: R. Zivadinov, PI for MRI; (PI: Robert Sawyer MD)
    Agency: Biogen Idec, Inc
    Aim: Evaluation of immune reconstitution and MS disease activity during a 6-months natalizumab discontinuation period in patients with relapsing Multiple Sclerosis after 24 months continuous natalizumab monotherapy.
    Period: December 2009 –December 2014
  • Magnetic resonance imaging (MRI) testing of active implantable medical devices (AIMDs).
    Role:
    R. Zivadinov, PI for MRI
    Agency: Greatbatch Medical.
    Aim: To examine certain MRI aspects of Greatbatch Medical product lines, such as batteries and capacitors.  Other aspects of this work will involve exploratory research into general physical principles, and/or potential solutions to identified MRI-AIMD compatibility problems.
    Period: January 2010 – December 2014
  • Evolution of gray matter (GM) atrophy over 4 years in observational study of early interferon (IFN)β-1a intramuscular (I.M.) (Avonex® ) treatment in high risk subjects after clinically isolated syndrome (SET substudy).
    Role:
    R Zivadinov, PI for MRI (PI: Dana Horakova, MD)
    Agency: Biogen Idec, Inc.
    Aim: To examine whether Avonex® can delay development of CDMS by slowing down gray matter atrophy progression. To investigate whether Avonex® can delay development of sustained disability by slowing down gray matter atrophy progression.
    Period: February 2009 – December 2014
  • 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 2015