COMMERCIAL ORGANIZATIONS GRANTS

  • 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
    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
  • Effect of teriflunomide (Aubagio®) on prevention of gray matter atrophy progression in clinically isolated syndrome patients. The post-hoc, blinded MRI analysis of TOPIC study using advanced MRI assessments.
    Role: R. Zivadinov, PI for MRI reanalysis.
    Agency: Genzyme Inc.
    Aim: The primary aim of this study is to compare the effect of teriflunomide (Aubagio®) vs placebo on the development of thalamus atrophy in patients with clinically isolated syndrome, participating in the TOPIC study.
    Period: August 2014 –December 2015
  • NeuroSTREAM – Neurological Software Tool for REliable Atrophy Measurement.
    Role: R. Zivadinov, Co-PI (PI: Michael G. Dwyer, PhD)
    Agency: Novartis, Inc.
    Aim: The goal of this study is to develop, validate and deploy 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 increasingly more novel and influential clinical research using data from clinical routine.
    Period: August 2014 –December 2015
  • 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
  • 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 2016
  • 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
  • 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
  • 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