Evaluating Bacopa for Gulf War Illness in Veterans

Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness

This study is testing whether Bacopa can help improve thinking and memory in Gulf War veterans who have Gulf War Illness.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 46 Years to 78 Years
• Sex: All
• Sponsor: Nova Southeastern University (Academic / other)
• Drugs / interventions: Rituximab, chemotherapy, radiation
• Locations: 1 site (Davie, Florida)
• Trial ID: NCT04927338 on ClinicalTrials.gov

What this trial studies

This phase II, double-masked, randomized, placebo-controlled study aims to assess the efficacy of Bacopa, a nutraceutical intervention, on cognitive function in Gulf War Veterans diagnosed with Gulf War Illness. The study will involve 170 participants who will be randomly assigned to receive either Bacopa or a placebo for 12 weeks. Evaluations will be conducted remotely using online assessment tools and telephone interviews, focusing on cognitive function and safety assessments. Participants will also undergo laboratory assessments to measure biomarkers related to neuron health and inflammation.

Who should consider this trial

Good fit: Ideal candidates are Gulf War Veterans born between 1942 and 1978 who meet specific diagnostic criteria for Gulf War Illness.

Not a fit: Patients with severe traumatic brain injury or those requiring hospitalization for comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve cognitive function and overall quality of life for veterans suffering from Gulf War Illness.

How similar studies have performed: While there have been studies on various interventions for Gulf War Illness, the specific use of Bacopa as a treatment is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Born in years 1942 to1978
2. Served in the Gulf War theater for any period between August 1990 and July 1991
3. Meets modified Kansas case definition criteria and CDC case definition for Gulf War Illness (GWI). The modified Kansas definition, which includes the CDC criteria includes:

   1. Allowance for normal illnesses of aging, such as hypertension and diabetes if the conditions are treated and are in demonstrable stable and normal ranges at the time of screening and assessment.
   2. Allowance of stable comorbid conditions such as post-traumatic stress disorder (PTSD), major depressive disorder (MDD), and traumatic brain injury (TBI) that have not required hospitalization in the 5 years prior to recruitment. Severe TBI is excluded.
4. Able to consent to the study
5. Participants of childbearing potential must practice effective contraception during the study so that, in the opinion of the Investigator, they will be compliant with birth control measures during the study.
6. Agrees to participate in follow-up visits.

Exclusion Criteria:

1. They are scheduled for a surgery during the period of study participation, had minor surgery within 3 months prior to screening, or had major surgery within 6 months prior to screening,
2. Self-report of current untreated major depression with psychotic or melancholic features (as determined by self-report), schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or substance abuse during the last two years (excluding cannabis products),
3. Any serious allergic disease (self-report), possibly resulting in anaphylaxis, such as food/drug allergies, including allergic asthma, or allergy to any ingredient of the active product or placebo, including allergies to FD\&C Yellow No. 5 (tartrazine),
4. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL or eGFR \< 44; or currently on renal dialysis),
5. Hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \>3x the upper limit of normal (ULN)). Participants with Gilberts syndrome are eligible for the study if other liver function tests are normal, regardless of bilirubin level,
6. Pregnancy (premenopausal female participants),
7. Current heavy alcohol or tobacco use (self-report). Heavy use is defined as alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day.
8. Current exclusionary diagnosis that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in the Ambiguities in case definition paper for Chronic Fatigue Syndrome (CFS), as described in detail in Reeves et al., 2003, which clarifies exclusionary conditions. Specifically, the exclusionary diagnoses that are not otherwise listed above comprise:

   * organ failure (e.g., emphysema, cirrhosis, cardiac failure, chronic renal failure)
   * chronic infections (e.g., AIDS, hepatitis B or C) or inflammatory bowel disease (IBD) (via self report)
   * major neurologic diseases that could cause fatigue or neurologic deficits such as (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease) or history of CNS demyelinating disease (e.g., multiple sclerosis, neuromyelitis optica spectrum disorder) (Self report),
   * cancer or cancer treatment (e.g., chemotherapy, radiation of brain), or current use of biologic modifiers that could affect immune function (e.g., Etanercept, Rituximab) (self-report)
   * untreated primary sleep disorders (e.g., sleep apnea, narcolepsy)
   * uncontrolled diabetes (HgbA1c \> 7)
9. Temporary conditions discovered at screening for which participants may be rescreened 6 weeks after resolution of condition.

   * Temporary effects of medications
   * Temporary sleep deprivation
   * Untreated hypothyroidism/hyperthyroidism, hypothyroidism/hyperthyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limit
   * Active infection
10. Participating in another interventional clinical trial of an investigational therapy (including social-behavioral therapy) within 6 weeks prior to consent to participate in this study, or planning to participate in another interventional clinical trial of an investigational therapy during this study,
11. Use of Bacopa within 6 weeks prior to the enrollment in this study,
12. Diagnosed bleeding disorder or current use of anticoagulants and/or antiplatelets, except for low dose nonsteroidal anti-inflammatories (NSAIDS).

Where this trial is running

Davie, Florida

• Nova Southeastern University — Davie, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Amanpreet Cheema, PhD — Nova Southeastern Univeristy
• Study coordinator: Mayra Vidro, MPH

Conditions Gulf War Illness; Veterans; Nutraceutical