Lithium in Inclusion Body Myositis (IBM)

Completed

Conditions studied: Inclusion Body Myositis

In brief

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

Key facts

Study ID

NCT00917956

Run by

Phoenix Neurological Associates, LTD

People needed

20

Starts

2008-06-01

Expected to finish

2009-12-01

Last updated by the study team

2010-02-26

Who can join

Age: 30 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >30
• Meet diagnostic criteria for definite IBM
• Muscle function adequate for quantitative muscle testing
• Able to give informed consent
• Women of child bearing potential must have a negative pregnancy test

You may not qualify if…

• Presence of uncontrolled diabetes, hypothyroidism, chronic infection, chronic renal insufficiency, congestive heart failure, cancer, or other chronic serious medical conditions
• Significant arrhythmias or conduction defect abnormalities on ECG
• Pregnant or lactating
• Coexistence of other neuromuscular or neurological diseases that would interfere with assessment
• Known bleeding disorder
• On Warfarin
• Contraindications to muscle biopsy: allergy to local anesthetic, skin infection, known bleeding disorder

Where it is running

• Phoenix Neurological Associates, LTD — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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