Inflammation Control For Elders: ICE Study — ICE  

Aging Clinical Trial

Official title: Role of Methotrexate in Improving Physical Function in Older Adults With Elevated Levels of Inflammation

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

If you decide to take part in this study, you will be randomly assigned (much like the flip of a coin) to receive either methotrexate or placebo. A placebo is a substance that looks like and is given in the same way as an experimental treatment but contains no medicine, for example [a sugar pill, an injection of saline (salt water)]. A placebo is used in research studies to show what effect a treatment has compared with taking nothing at all. If you are assigned to receive placebo, you will not receive the benefits of the methotrexate, if there are any, nor will you be exposed to its risks, which are described below under "What are the possible discomforts and risks?" Studies have shown, however, that about 1 in 3 persons who take a placebo do improve, if only for a short time. You and the physician and other persons doing the study will not know whether you are receiving placebo or methotrexate, but that information is available if it is needed. Also, you will have a 50% chance of receiving methotrexate and a 50% chance of receiving placebo.

Methotrexate lowers folate (vitamin B9) levels in the body, so when someone takes methotrexate, he/she needs to take folic acid. To make sure that methotrexate lowers levels of inflammation in the body and not folate, study participants in both groups will be given folic acid.

In the remainder of the description of what will be done, both the methotrexate and the placebo will be called "study treatment."

You will be given a study letter that describes the study. You will be asked to show this letter to your doctors and other medical specialists, so they know that you are participating in a study with study drugs.

You will be asked to take your study drugs every morning by mouth on an EMPTY STOMACH before breakfast. The study capsules containing methotrexate and the placebo will look the same.

Participants in the methotrexate group will slowly increase the amount of methotrexate they take in the first month up to the 15 mg/week. In the first week, participants will take 5 mg/week (i.e., 1 capsule on Day 7), in the second and third week they will take 10 mg/week (i.e., 2 capsules on Day 7), and in the fourth week they will take 15 mg/week (i.e., 3 capsules on Day 7). On Days 1-6, participants will take 1 folic acid capsule.

Participants in the placebo group will slowly increase the number of placebo capsules they take in the first month. In the first week, participants will take 1 placebo capsule on Day 7, in the second and third week they will take 2 placebo capsules on Day 7, and in the fourth week they will take 3 placebo capsules on Day 7. On Days 1-6, participants will take 1 folic acid capsule.

Store study medications at room temperature between 59° to 86°F (15° to 30°C) and keep them away from light.

Keep these and all medicines out of the reach of children.

You will be asked to take the study drugs for 6 months, and your participation in the study will last approximately 8 months. The investigators will ask you to attend 12 study visits at the research center located at the Institute on Aging - Clinical & Translational Research Building (IOA - CTRB):

1. Screening Visit

2. Baseline Visit

3. Baseline Functional Magnetic Imaging (fMRI) Visit

4. 1-Month Visit

5. 2-Month Visit

6. 3-Month Visit

7. 4-Month Visit

8. 5-Month Visit

9. 6-Month Visit

10. 6-Month fMRI Visit

11. Follow-Up Visit I

12. Follow-Up Visit II

The investigators will also call you approximately 9 times during the study to ask you how you feel and to find out if you remembered to take all your study drugs. ;

Related Conditions & MeSH terms

• Aging
• Inflammation

• NCT number: NCT02079948
• Study type: Interventional
• Source: University of Florida
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2014
• Completion date: September 2014