ALS Disease Markers Study: Open to Enrollment
A team of scientists at Columbia University Principal Investigator under the direction of Hiroshi Mitsumoto, MD are beginning a study of "Diagnostic and Natural History Markers in ALS". This is an important study for developing objective markers in ALS. The results may have a large impact on diagnosis as well as treatment options in ALS.
Rapid progress in basic research, however, has introduced several different approaches to developing new treatments. A number of new therapeutic agents appear likely to become available for clinical trials in ALS in the next several years. To determine the effectiveness of these agents, objective and effective diagnostic surrogate markers for diagnosis and clinical trials are essential. However, no reliable objective measures are available for ALS, one of most serious deficiencies in the field.
To address this deficiency, the study proposes to:
(1) Investigate several novel technologies to establish objective upper motor neuron (UMN) and lower motor neuron (LMN) markers for the early and accurate diagnosis of ALS
(2) Determine whether these markers can provide clinically meaningful data and allow us to detect changes over time with high sensitivity
(3) Determine whether these markers can improve the prediction of ALS disability and survival.
This project is the first step toward the eventual establishment of biological markers for clinical trials and is the first comprehensive investigation that seeks to identify diagnostic and natural history markers in ALS using currently available novel technologies. We believe that our study will expand understanding of the pathophysiology of ALS. The results of our project will allow for increasing numbers of potential therapeutic agents to be studied in clinical trials and eventually for improvement in the diagnosis and care of patients with this disease.
We have recently completed the preliminary studies with healthy volunteers and are ready to begin enrolling patients diagnosed with ALS. It is essential for the success of this study that we have patient volunteers for this program.
If you are interested, please call the ALS Center at 212-305-5105.
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