ARMS is pleased to endorse for fund-raising support the following study, approved by the Institutional Review Board of the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University at New York. ARMS has committed to raise $75,000 in support of the MS Progression and Aging Study, which is a patient-centered study.
The ARMS Board was drawn to this study because it may provide a “roadmap” for lifestyle choices that could be of great benefit to anyone with MS! The Board is also pleased to support the addition of the Age 60 and Older patient cohort to this study for the following reasons:
· There is a lack of clinical trial data on patients age 60 and older, because they are generally excluded from most study designs (due to co-morbidities), despite the fact that this age group now represents 20 % of the MS population. This study will advance the information and better understanding of the difference between MS disease progression vs. aging with MS.
· Including patients in this age group may offer the opportunity to assess the impact of lifestyle choices made BEFORE the introduction of the first Disease Modifying Therapies (DMT’s) beginning in 1993.
· Including patients age 60 and older provides valuable data on the potential sequelae from long term use of Disease Modifying Therapies (DMT’s) that suppress the immune system.
This research is being conducted with 196 participants age 60 or older. Of these, 94 patients have MS, 14 have other neurological diseases, and 88 are control subjects who do not have MS or other neurological disorders. All subjects have been selected from among those who participated in a 2009-10 study of over 1,000 subjects performed in the Department of Neurology, University at Buffalo School of Medicine, Buffalo, New York.* This new 5-year follow-up study will include new MRIs of the brain and spinal cord with analyses being performed by the Buffalo Neuroimaging Analysis Center (BNAC) under the direction of Robert Zivadinov, MD, PhD. Clinical evaluation of the subjects are being performed at the Jacobs Neurological Institute of the Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, located at the Buffalo General Medical Center.
Goals of the Study
The researchers are seeking to learn
· what factors influence disease progression
· what affects the speed of disease progression
· what are the predictors for relentless, sustained deterioration
· what therapies and/or dietary and life style changes are most beneficial.
Specifically, the study is designed to:
1. Identify the clinical, neurological, and socio-economic characteristics associated with MS progression in patients over 60 years old.
Patient-reported outcomes, regarding their perception of physical and psychosocial function and these changes over time, will also be studied. Comparisons will be made between those with MS to control participants and to people with other neurological disorders.
2. Investigate the cumulative use and effect of MS Disease Modifying Therapies (DMT’s).
3. Examine the roles of genetic and environmental factors.
The researchers will identify genetic markers implicated in the risk of developing MS, to assess whether these genes also affect the risk of disease progression. They will also assess whether biomarkers of environmental exposure to Epstein-Barr Virus (EBV), and Cytomegalovirus (CMV), as well as smoking, are associated with an increased risk of progression. Serum lipid levels, vitamin D levels, and inflammatory markers (CRP and IL-6, Zn) will also be evaluated to assess the role of dyslipidemia and chronic inflammation as co-morbidities to disease progression.
Significance of This Research
This study is novel because it also focuses on monitoring an aging MS population that are usually not included in clinical trials, but can provide valuable new insights to the study objectives. Successful completion of this study will have immediate impact as the information gained will not only advance the insights on patients aging with MS, but will also suggest what interventions (existent therapies, life style changes et al) would most benefit the course at an individual patient level.
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Bianca Weinstock-Guttman, MD
Professor of Neurology
State University of New York at Buffalo
Director, Jacobs MS Center for Treatment & Research
Director, Jacobs Pediatric MS Center of Excellence
Executive Director, NY State MS Consortium