Inclusion Body Myositis Clinical Trial
Official title:
A Pilot Trial of Lithium in Inclusion Body Myositis (IBM)
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.
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Observational Model: Cohort, Time Perspective: Prospective
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