The Rocky Mountain Neurology Translational Research Laboratory has been up and running for about two years now, with researchers from the Rocky Mountain MS Center at CU taking the lead on several studies. Below are a few of the MS Research team’s top priorities.
NfL and GFAP as Measures of Disease Progression
Prospective study to evaluate Neurofilament Light (NfL) and glial fibrillary acidic protein (GFAP) as biomarkers for disease progression over time in patients with multiple sclerosis and other inflammatory neurological diseases. This study includes treatment of patients newly diagnosed with MS, neuromyelitis optica (NMO), neurosarcoidosis, or autoimmune encephalitis. Serum and plasma samples are drawn from newly diagnosed patients who have yet to start treatment.
Additional plasma and serum samples will be collected after patients begin treatment, and approximately every six months when patients return to clinic. Over time, NfL and GFAP will be monitored to determine if these proteins can be used as reliable indicators of disease progression.
Identifying Potential MS Biomarkers
Ongoing cross sectional exploratory study to identify potential biomarkers that represent injury to the three different key Central Nervous System (CNS) compartments including the neuronal compartment, astrocyte compartment, and oligodendrocyte compartment in patients with MS and related inflammatory CNS diseases. This study includes controls and patients diagnosed with multiple sclerosis, NMO, neurosarcoidosis, or autoimmune encephalitis who are seen by the neurology providers at UCH and have consented to inclusion in the RMMSC Biorepository. Patients will contribute paired CSF and blood samples collected at the time of a lumbar puncture, and stored in the RMMSC biorepository. These samples will be analyzed for biomarkers of interest, including GFAP (astrocytes); NfL (neuronal); Tau (neuronal); UCHL1 (neuronal); and MBP (oligodendrocyte). The resulting information will be used to develop future biomarker tests for clinical trials and clinical use.
Measuring the Effect of DMTs
A prospective, cross-sectional, case-controlled study comparing the effectiveness of common disease modifying therapies prescribed for multiple sclerosis based on evaluation of biomarkers indicative of subclinical disease. The initial results of this study have been presented, and the study is ongoing to continue collecting more samples. The study includes patients diagnosed with multiple sclerosis, NMO, neurosarcoidosis, or autoimmune encephalitis who have been stable on one DMT for at least 12 months with no disease breakthrough activity. Patients will be matched based on age, sex, and disease duration between four treatment groups. Patients will be identified and have blood drawn (serum and plasma) one time at their standard of care appointments. Samples will be analyzed on the Simoa platform for all of the above biomarkers (particularly NfL) to see how their levels differ between treatment groups. By looking at biomarkers indicative of subclinical disease, the data will lay the foundation for later biomarker studies and combination therapy trials using newer neuroprotective therapies.
Discontinuing DMTs
A prospective, longitudinal, exploratory biomarker study on stable patients with multiple sclerosis or other inflammatory neurologic disorders who are discontinuing DMTs. The question of whether or not stable patients can safely discontinue taking a DMT is a key issue facing the field of MS treatment today. This study will collect a baseline blood sample from patients who are discontinuing DMTs, prior to stopping their drug. Additional blood samples will be collected every six months during routine follow up visits for up to five years. This will allow researchers to track the changes in NfL and other biomarkers over time in stable patients with MS who have discontinued treatment with DMTs to determine if these patients remain in remission, or if some reactivate their MS and require further treatment.
