New study to examine the effects of MS disease-modifying therapy on cognitive fatigue

Kessler Foundation researchers have received support from Genentech, a member of the Roche Group, to conduct an investigator-initiated study on the effects of ocrelizumab (Ocrevus) on cognitive fatigue in individuals with relapsing-remitting multiple sclerosis (MS).

John DeLuca, PhD, senior vice president of Research and Training, is principal investigator for the study titled, "A Biomarker for Cognitive Fatigue in MS using Functional Imaging". The study team includes Glenn Wylie, DPhil, director of the Rocco Ortenzio Neuroimaging Center at Kessler Foundation, Ekaterina Dobryakova, PhD, research scientist in the Center for Traumatic Brain Injury Research, and Helen Genova, PhD, assistant director of the Center for Neuropsychology and Neuroscience Research.

Cognitive fatigue can have dramatic negative impact on everyday life activities of individuals with MS. Reported in 70 to 90% of patients, cognitive fatigue is difficult to treat, in large part because researchers and clinicians have lacked a physiological marker for cognitive fatigue. None of the available medications or disease-modifying therapies for MS are indicated for the treatment of cognitive fatigue.

Using the unique research capabilities for functional neuroimaging at the Ortenzio Center, Foundation scientists have identified a physiological marker for cognitive fatigue and validated it in MS. Their goal for the current study is to provide initial data that suggest the effects of ocrelizumab on this objective marker of cognitive fatigue in MS.

The 3-year study involves three groups: 1) individuals with MS who will begin taking ocrelizumab (Ocrevus), 2) individuals with MS who will begin taking Copaxone; (glatiramer acetate injection), and 3) healthy controls, all of whom will be matched on age, education and gender. Levels of cognitive fatigue and associated brain activity will be assessed in these groups at baseline, 6 months and 12 months following the start of treatment.

Functional imaging enables us to look at the specific brain areas that underlie cognitive fatigue, and follow any changes in fatigue patterns during Ocrevus therapy. Using our physiological marker in this rigorously designed study, we will be able to determine the impact of ocrelizumab on cognitive fatigue in individuals with MS. Exploring the impact of pharmacological therapies on cognitive fatigue is an important step toward expanding options for treating this disabling symptom."

Dr. John DeLuca, PhD, Senior Vice President, Research and Training

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