Actively Recruiting
Clinical Evaluation of Montelukast on Cognitive and Mood Dysfunction and Neuroinflammation in Veterans With Gulf War Illness
Led by Baylor College of Medicine · Updated on 2025-08-20
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
M
Michael E. DeBakey VA Medical Center
Collaborating Sponsor
AI-Summary
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 Montelukast's 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.
CONDITIONS
Brief Title
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gulf War Veterans of the U.S. military deployed to the Persian Gulf between August 2, 1990 and December 31, 1991
- Diagnosed with Gulf War Illness according to CDC and modified Kansas criteria, with symptoms in at least 3 of 6 domains including fatigue, neurological, pain, gastrointestinal, respiratory, or skin symptoms
- Self-reported cognitive dysfunction with a T-score of 40 or less on the PROMIS v2.0 Cognitive Function 8a short form
- Able to provide written consent and communicate in English
- Able to attend two in-person study visits and have reliable telephone service for weekly phone contacts
You will not qualify if you...
- Diagnosed with chronic autoimmune or systemic inflammatory conditions
- Cancer not in remission for at least 5 years
- Congestive heart failure, anemia, multiple sclerosis, amyotrophic lateral sclerosis (ALS), or poorly controlled diabetes
- Post-chemo or radiation syndromes
- Sickle cell anemia or symptomatic coronary artery disease
- Chronic liver disease or chemical insufficiency
- Morbid obesity (BMI ≥ 40)
- HIV infection
- Substance use disorder or misuse of certain drugs in the past year
- Major mental health conditions interfering with symptom reporting
- Hospitalization or invasive procedures in the past 12 months due to chronic condition exacerbations
- Elevated liver enzymes or low kidney function at baseline
- Hemoglobin less than 10 g/L at baseline
- Recent medication changes for chronic conditions in the past 3 months
- Suicidal or homicidal ideation
- Use of Montelukast in last 6 months
- Taking two or more medications that interact moderately with Montelukast
- Pregnancy or intention to become pregnant
- COVID-19 illness without recovery to pre-COVID health status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants take two capsules of montelukast or placebo once daily for ten weeks to evaluate effects on cognitive function, mood, and neuroinflammation.
2 visits (in-person) and weekly phone contacts
Trial Site Locations
Total: 1 location
1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jason K Aguilar, BA
K
Kandice Motley, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here