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Study Description

Disability Progression and Aging in Multiple Sclerosis

A 5-Year Follow-Up Study

  • Of the estimated 400,000 people in the US with MS, approximately 78,000 (fewer than 20%) are 60 or older.

  • 60-80% of people 60 or older who have had MS for 15 years or longer are in the progressive phase of the disease

  • Nearly 80% of people diagnosed with MS in the US are being treated with disease-modifying therapies (DMT), including those with progressive forms of MS

  • Because few studies are done for this age group, there is insufficient research available to understand the implications of DMTs for those in the progressive stage of MS

Study Design

This research will be conducted with 196 participants age 60 or older. Of these, 94 will have MS, 14 will have other neurological diseases, and 88 will be control subjects who have no MS or other neurological disorders. All subjects will be 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, Buffalo, New York.* This new 5-year follow-up study will include new MRIs of the brain and analyses to be performed by the Buffalo Neuroimaging Analysis Center (BNAC) under the direction of Robert Zivadinov, MD, PhD. Clinical evaluation of the subjects will be performed at the Jacobs MS Center located at the Buffalo Medical Institution. New blood samples or genetic testing will also be drawn.

Goals of the Study

The researchers will seek to learn what factors protect against disease progression, what affects the speed of disease progression, what are the predictors for relentless, sustained deterioration, and which therapies and/or dietary and life style changes are most beneficial.

1. Identify the clinical, neurological, and socio-economic characteristics associated with MS progression in patients over 60 years old

2. Investigate the cumulative use and effect of MS DMTs

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 who do not have MS and to people with other neurological disorders.

3. Examine the roles of genetic and environmental factors

The researchers will Identify genetic markers with a focus on which gene sequences might be implicated in the risk of developing MS. They will assess whether they also affect the risk of progression either alone or in combination with other MS risk genes or genes related to extended life expectancy. They will study how vitamin D levels, viruses such as Epstein-Barr virus and herpes, smoking, serum lipids, and inflammatory markers are associated with an increased risk for disease progression.

Significance of This Research

The research work will bring new insight into the nature of multiple sclerosis and provide information that may lead to practical ways in which the quality of life for people 60 years or older with MS can be improved.

This study is novel because it focuses on monitoring people with MS patients who are 60 or older, a group that is rarely included in clinical trials. The fact that this population, mostly with a progressive form of the disease, has a history of long-term use of disease modifying therapies should prove this research to be very interesting scientifically and the implications of the study may have important practical and immediate value for patients. 

* The baseline cross-sectional group of these subjects included 1,012 subjects. Of these, 569 had MS, 67 had a designation of “clinically isolated syndrome, 298 were control subjects without MS symptoms, and 78 who were diagnosed with another neurological disorder. All subjects in that study were evaluated with a full neurological and physical exam, brain MRI including quantitative analysis, an extensive questionnaire including dietary information, leisure activity, sun exposure and information about other diseases. All subjects provided blood samples for environmental and genetic factors. Subjects over 60 yr. old from this large group will be included in this new, follow-up study with more extensive assessments including the MS functional composite (MSFC) test and the single digit modality test (SDMT).

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