Clinical Evaluation of Montelukast on Cognitive and Mood Dysfunction and Neuroinflammation in Veterans With Gulf War Illness (GWI)
Baylor College of Medicine
Summary
The study addresses the pre-clinical promise of Montelukast (MLK) for improving brain function in veterans with Gulf War Illness (GWI). MLK, a US Food and Drug administration (FDA)-approved drug for asthma, has shown efficacy in an animal model of GWI to improve cognitive and mood function through modulation of leukotriene signaling and suppression of neuroinflammation.
Description
Background: Approximately 30% of Gulf War Veterans (1990-1991) suffer from Gulf War Illness (GWI), a chronic condition characterized by disabling symptoms in multiple domains. Animal models and human data suggest a prominent neuroinflammatory basis for many of the symptoms of GWI. Preliminary data from an established GWI rat model demonstrates the involvement of increased leukotriene signaling in the brain and its potential as a marker of neuroinflammation when detected in neuron- and astrocyte-derived extracellular vesicles present in the peripheral blood. MLK, an FDA-approved drug for asthma…
Eligibility
- Age range
- 50–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Gulf War Veterans of the U.S. military deployed on military orders to the Persian Gulf Region between August 2, 1990, and December 31, 1991 * Diagnosed with GWI according to the CDC and modified Kansas criteria as recommended by the Institute of Medicine (IOM), that is, endorse multiple or moderate-to-severe symptoms, with symptom onset during or after deployment to the Persian Gulf region in 1990-1991, persisting for six months or longer, in at least 3 of 6 domains: 1. fatigue/sleep disturbances 2. neurological/cognitive/mood symptoms 3. somatic pain 4. gastroi…
Interventions
- DrugMontelukast
This group will receive the montelukast treatment.
- OtherPlacebo
This group will receive a placebo pill instead of montelukast
Location
- Michael E. DeBakey VA Medical CenterHouston, Texas