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Inflammation Control For Elders: ICE Study

NCT02079948 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-01-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Methotrexate + Folic Acid

Participants in the methotrexate + folic acid condition will have a * Blood draw at each monthly visit * Cognitive performance testing to assess memory performance * Physical function testing to assess walking speed and measure muscle endurance * Pain assessment testing to assess the presence and location of daily pain * Self-reported function and quality of life to measure disability and mobility limitations, and * Depression assessment testing to assess participants' level of depression.

DRUG

Placebo + Folic Acid

Participants in the placebo + folic acid condition will have a * Blood draw at each monthly visit * Cognitive performance testing to assess memory performance * Physical function testing to assess walking speed and measure muscle endurance * Pain assessment testing to assess the presence and location of daily pain * Self-reported function and quality of life to measure disability and mobility limitations, and * Depression assessment testing to assess participants' level of depression

PROCEDURE

Functional MRI Experimental Tasks

Participants who are randomly assigned to the fMRI scan wil receive their study drugs at the the Baseline fMRI visit. Participants who are randomly assigned to the fMRI will also attend complete their last visit at the 6 month period.

PROCEDURE

Muscle Biopsy

Participants who are randomly assigned to the muscle biopsy assessment of the study will receive their study drugs at the Baseline muscle biopsy visit. Participants who are randomly assigned to the muscle biopsy portion of the study will also complete their last visit at the 6 month period.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Stephen Anton, PhD · University of Florida, Institute on Aging

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-09-30
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02079948 on ClinicalTrials.gov