Study of Montelukast to Improve Brain Function and Mood in Veterans With Gulf War Illness

What this Trial Is About

Researchers are evaluating the potential of Montelukast, a drug approved by the FDA for asthma, to improve brain function in veterans suffering from Gulf War Illness GWI. GWI is a chronic condition affecting about 30% of Gulf War veterans, characterized by symptoms across multiple areas including cognition and mood. The study focuses on Montelukasts ability to reduce neuroinflammation by modulating leukotriene signaling, which has shown promise in animal models and is believed to be a key factor in GWI symptoms. Participants will be randomly assigned to receive either Montelukast, two capsules of 20 mg each daily for ten weeks, or a placebo of two capsules daily for the same period. This double-blind, placebo-controlled trial involves 80 veterans who meet specific criteria for GWI and cognitive dysfunction. The study includes two in-person visits for assessments and blood draws, with regular phone contacts throughout the study. During the trial, participants will complete neurocognitive tests, self-reported questionnaires on mood and physical function, and provide blood samples to measure leukotriene levels as markers of brain inflammation. The primary outcome is the change in leukotriene concentration from baseline to week 10. Secondary outcomes include changes in cognitive function and physical health scores. The study team will monitor participants progress and safety, with the total involvement lasting about ten weeks.

Clinical Evaluation of Montelukast in Veterans With Gulf War Illness