Inflammation Control For Elders: ICE Study

• Status: Withdrawn
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be the first to test whether a selected anti-inflammatory agent, methotrexate, reduces inflammation in a human body, improve cognitive and physical function, and reduce pain levels in older adults at risk for functional decline, due to systemic inflammation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Collaborator: National Institute on Aging (NIA)
• Treatments: Folic Acid; Methotrexate; Vitamin B Complex

Criteria

Inclusion Criteria:

• 65 years of age or over

• Blood Level of IL-6: > 2.54 pg/mL

• Physical Activity: < 120 minutes of moderate intensity physical activity per week

• Mild-to-moderate physical impairment: (SPPB < 9)

• Blood Pressure: < 160/90 mm Hg

• Willing and able to give informed consent

Exclusion Criteria:

• Significant underlying disease that is likely to limit participation and/or increase risk of interventions

• History or diagnosis of cardiovascular disease, myocardial infarction (heart attack), cerebrovascular accident, or unstable angina NYHA Class 3 or 4 congestive heart failure; aortic stenosis; cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina within the past 6 months;

• History or diagnosis of severe lung disease within the past 6 months

• Known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; Lymphoproliferative disease diagnosed and/or treated within the last five years; non-basal cell malignancy

• Prior history of chronic infectious disease, renal insufficiency, interstitial lung disease, pneumonitis, bronchiectasis, pulmonary fibrosis, or pulmonary disease

• Cognitive impairment and/or diagnosis of dementia

• Failure to provide informed consent

• Current usage of methotrexate therapy

• Consume alcohol and refuses to reduce alcohol use to 3 or fewer drinks per week during the study

• History of drug or alcohol abuse or excessive alcohol use within past six months

• Abnormal laboratory values

• White blood cell count < 4,000/ul, hematocrit < 32%, or platelet count < 75,000/ul

• Liver transaminase levels (AST or ALT) > upper limit of normal (ULN) or albumin < the lower limit of normal (LLN)

• Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation

• Hypercalcemia (calcium > 10.4 mg/dL), hypocalcemia (calcium < 8.6 mg/dL), renal insufficiency (estimated glomerular filtration rate (eGFR) < 50 ml/min)

• Lives in a nursing home

• Self-reported inability to walk one block without any type of assistive device

• Chest pain or severe shortness of breath during the 400-meter walk test

• Terminal illness with life expectancy less than 12 months, as determined by a physician

• Medication exclusions (current use of anabolic medications [i.e., growth hormones or testosterone], antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors [i.e., Aricept], anticoagulant therapies [aspirin use is permitted], antibiotics for HIV or TB, or antibiotics for other uses currently or within the past two months)

• Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers

• Requirement for use of drugs that alter folate metabolism or reduce tubular excretion or known allergies to antibiotics making avoidance of trimethoprim impossible

• Planning to leave the area in the next year

• Current smoker or less than 3 years quit

• Men who plan to father children during the study period or who are unwilling to use effective forms of contraception

• Women of child bearing potential

• Other significant co-morbid disease (e.g., renal failure on hemodialysis)

• Contraindications to fMRI (ex. cardiac pacemaker)

• Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment

• Any other condition that in the opinion of the principal investigator may compromise the participation in the study

• Participants with contraindications to the muscle biopsy procedure can participate in the study but will not be asked to participate in the muscle biopsy procedure.

The temporary exclusions include the following:

• Recent bacterial/viral infection (< 2 weeks)

• Acute febrile illness in prior 2 months

• Major surgery or hip/knee replacement in the past 6 months