An observational study in Inclusion Body Myositis, sponsored by Phoenix Neurological Associates, LTD. Completed at 1 site in United States. Open to participants aged 30 Years to 88 Years. Per ClinicalTrials.gov, last updated 2010-02-26.
Sponsored by Phoenix Neurological Associates, LTD · Observational
IBM is the most common acquired muscle disease occurring over the age of 50. The underlying cause remains unknown and there is currently no effective treatment. Pathological studies have revealed abnormal collections of proteins in the muscle cells from patients with IBM. These include proteins called phosphorylated tau (p-tau). A similar process appears to occur in Alzheimer disease, with accumulations of p-tau developing in brain cells. Lithium decreases the activity of the GSK, an enzyme that has a key role in the development of p-tau. Lithium and other GSK inhibitors have been shown to decrease the accumulation of p-tau in nerve cells in animal models of Alzheimer disease. The proposed research is a pilot study to see if lithium might be an effective treatment for IBM
Trial Status Open for Enrollment
What is the Purpose of this Study? There is currently no effective treatment for IBM and its pathogenesis remains uncertain. This study is designed to test the hypothesis that treatment of patients with IBM with Lithium can improve muscle strength and reduce the markers of disease activity believed to be important in the disease pathogenesis.
Who is Eligible to Participate? Patients diagnosed with Inclusion Body Myositis above the age of 30 who have adequate muscle function for quantitative muscle testing and who have a FVC >50%. Patients who have uncontrolled diabetes, renal insufficiency, congestive heart failure, cancer, hypothyroidism, current use of immunosuppressive medication, currently on warfarin or any known bleeding disorder are excluded.
What is involved in this Study? This is an open label trial looking at the effects of Li on muscle strength. Procedures consist of a baseline muscle biopsy, blood work, and other screening procedures. After the muscle biopsy patients are started on Li at 300mg/d. Lithium doses are dependent on tolerability and target lithium levels. Monthly visits consist of EKGs, Li level labs, questionnaires, and muscle strength testing. At month 6, patients will receive another muscle biopsy. The muscle biopsies are performed to analyze p-tau levels in the muscle.
How long is the Study? It is approximately 6 months long; however patients have the option to stay on the study for an additional 6 months.
242 studies on the registry are indexed under Myositis; 103 are open to participants now.
This study's planned enrollment of 20 is below the median of 226 across 72 observational studies indexed under Myositis.
Browse Myositis studies →Phoenix Neurological Associates, LTD is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who fit criteria diagnosed with IBM
Exclusion Criteria:
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Phoenix Neurological Associates, LTD