Study of Bacopa in Gulf War Illness Patients

NCT04927338 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GWICTIC-BacopaW81XWH1820062
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal/joint pain. This phase II, double masked, randomized, placebo-controlled, two-arm study will evaluate cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness, along with assessments of safety of the intervention.

Conditions

Gulf War Illness

Keywords

Veterans; Gulf War Illness; Nutraceutical

Outcome Measures

Primary Outcomes (1)

• California Verbal Learning Test (CVLT-II) Assessment

  Change in mean CVLT-II long delay free recall from baseline to 12 weeks. Higher CVLT-II scores are considered clinically better, and the raw CVLT-II scores will be used in analyses and reporting.

  12 weeks

Secondary Outcomes (4)

• Blood Biomarker Concentrations

  12 weeks

• Veterans RAND 36 Item Health Survey (VR-36©)

  12 weeks

• Veterans RAND 36 Item Health Survey (VR-36©)

  16 weeks

• Review of Treatment Related Adverse Events

  16 weeks

Study Arms (2)

BacoMind® 300mg/day

EXPERIMENTAL

Participants randomized to the experimental arm will receive 12 weeks of 300 mg/day BacoMind® Bacopa monnieri standardized extract.

Dietary Supplement: BacoMind® (Bacopa monnieri standardized extract)

Placebo

PLACEBO COMPARATOR

Participants randomized to the placebo arm will receive 12 weeks of daily placebo identical to the experimental treatment in size, color, and shape.

Drug: Placebo

Interventions

BacoMind® (Bacopa monnieri standardized extract) DIETARY_SUPPLEMENT

BacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.

Also known as: Bacopa, Bacopa monnieri

BacoMind® 300mg/day

Placebo DRUG

Daily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.

Placebo

Eligibility Criteria

• Age: 46 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Born in years 1942 to1978
• 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 (GWI). The modified Kansas definition, which includes the CDC criteria includes:
• 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.
• 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 the opinion of the Investigator, they will be compliant with birth control measures during the study.
• Agrees to participate in follow-up visits.

You may not qualify if:

• 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,
• 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),
• 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),
• Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL or eGFR \< 44; or currently on renal dialysis),
• 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 (premenopausal female participants),
• 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.
• 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)
• Temporary conditions discovered at screening for which participants may be rescreened 6 weeks after resolution of condition.
• Temporary effects of medications

Sponsors & Collaborators

• Nova Southeastern University: lead
• RTI International: collaborator
• Boston University: collaborator

Study Sites (1)

Nova Southeastern University

Davie, Florida, 33314, United States

RECRUITING

Study Officials

• Amanpreet Cheema, PhD

  Nova Southeastern Univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayra Vidro, MPH

CONTACT

954-262-2841; mvidro@nova.edu

Karen Kesler, PhD

CONTACT

919-485-1429; kkesler@rti.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, care providers, investigators, study coordinators, and laboratory technicians will be masked to the participants' treatment group status. Placebo capsules will be identical in size, color, and shape to that of the Bacopa capsules.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a double-blinded, two-arm, placebo-controlled, randomized phase II study in 170 participants born between 1946 and 1978 who are Gulf War Veterans and meet the modified Kansas and Centers for Disease Control and Prevention (CDC) case definition for Gulf War Illness.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 16, 2021
• Study Start: December 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)