Study of Bacopa in Gulf War Illness Patients

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this phase II study is to evaluate the efficacy and safety of Bacopa monnieri standardized extract (300 mg/day) taken for 12 weeks in 264 veterans with GWI, and to gain insight into the underlying biological mechanisms of nootropic, anti-inflammatory, and adaptogenic actions tied to Bacopa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Southeastern University
• Collaborators: Boston University; RTI International

Criteria

Inclusion Criteria:

• Age 47 to 70 years old

• Served in the Gulf War theater for any period between August 1990 and July 1991

• Meets modified Kansas case definition criteria and CDC case definition for Gulf War Illness. The modified Kansas definition, which includes the CDC criteria includres:

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.

• Able to consent to the study

• Participants of childbearing potential must practice effective contraception during the study so that, in opinion of the Investigator, they will be compliant with birth control measures during the study.

• Agrees to participate in follow-up visits.

Exclusion Criteria:

• They are scheduled for surgery within 20 weeks of study enrollment

• Current treated or untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias of any type, and alcoholism or drug abuse (as determined by self-report and the web-based Structured Clinical Interview for DSM-5 (NetSCID-5)), or a history of CNS disorders that may affect cognitive function (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease)

• Chronic active infections such as HIV, hepatitis B, or hepatitis C (as determined by antibody tests)

• Current primary sleep disorders (self-report)

• Any serious allergic disease (self-report), possibly resulting in anaphylaxis, such as food/drug allergies, including gelatin, and allergic asthma

• Use of medications that could affect immune function (e.g., steroids, immunosuppressants) (self-report)

• Renal insufficiency with serum creatinine > 2.0 mg/dL

• 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

• Pregnancy

• 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.

• Current heavy alcohol or tobacco use (self-report). 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.

• Diagnosis of CNS demyelinating disease (e.g., multiple sclerosis, neuromyelitis optica spectrum disorder)

Prohibited Concomitant or Prior Therapies:

• Use of Bacopa within 6 months prior to enrollment in this study

• Currently on dialysis

• Participating in another interventional clinical trial of an investigational therapy within 8 weeks prior to consent to participate in this study, or planning to participate in another interventional clinical trial of an investigational therapy within 20 weeks after consent to participate in this study

• Current use of drugs that impact cognitive function or oxidative stress, as deemed by the research pharmacist, such as carbamazepine, valproate, lamotrigine, AChE inhibitors, or cholinergic drugs.