Lithium in Inclusion Body Myositis (IBM)
Li-IBM
A Pilot Trial of Lithium in Inclusion Body Myositis (IBM)
2 other identifiers
observational
20
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 26, 2010
February 1, 2010
1.4 years
June 8, 2009
February 25, 2010
Conditions
Keywords
Eligibility Criteria
Patients who fit criteria diagnosed with IBM
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Phoenix Neurological Associates, LTD
Phoenix, Arizona, 85018, United States
Biospecimen
Muscle Biopsies will be taken at baseline and at the end of 6 months. Tissue will be frozen then sent out for anaylsis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David D Saperstein, MD
Phoenix Neurological Associates, LTD
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 11, 2009
Study Start
June 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
February 26, 2010
Record last verified: 2010-02