Bacopa for Gulf War Syndrome

Overseen By Mayra Vidro, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nova Southeastern University

Must not be taking: Anticoagulants, Antiplatelets, Biologics, Bacopa

Disqualifiers: Surgery, Untreated depression, Allergies, Renal disease, Hepatic insufficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a natural supplement called Bacopa (also known as BacoMind® or Bacopa monnieri) might help manage symptoms like memory and thinking difficulties in those with Gulf War Illness. Participants will receive either Bacopa or a placebo (a pill with no active ingredient) to determine if it improves cognitive function and is safe to use. The trial seeks Gulf War veterans experiencing symptoms such as fatigue, headaches, and sleep problems. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you have stable conditions like hypertension or diabetes. You cannot use Bacopa or certain blood thinners before joining the study.

Is there any evidence suggesting that BacoMind® is likely to be safe for humans?

A previous study administered Bacopa monnieri, the main ingredient in BacoMind®, to participants to assess its safety. The study found that Bacopa is generally well-tolerated, with most participants not experiencing serious side effects. Some reported mild side effects, such as an upset stomach or fatigue, but these were uncommon.

BacoMind® has undergone testing in other clinical trials, indicating that its safety has been reviewed before. The current phase 2 study suggests that earlier research deemed it safe enough for testing in a larger group. If Bacopa monnieri posed serious risks, it would not have advanced to this phase.

Overall, Bacopa monnieri has demonstrated a good safety record in past studies. However, like any treatment, it is important to be informed and consult a doctor before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Gulf War Illness?

Unlike the standard treatments for Gulf War Syndrome, which often include medications for symptom management like pain relievers and antidepressants, BacoMind® offers a unique approach by harnessing the power of Bacopa monnieri, a plant traditionally used in Ayurvedic medicine. Researchers are excited about BacoMind® because it targets cognitive function and mental clarity, which are key areas affected in Gulf War Syndrome, with its natural, standardized extract. This treatment is particularly intriguing because it may provide cognitive benefits without the side effects commonly associated with pharmaceuticals, potentially offering a safer and more holistic option for those affected by this condition.

What evidence suggests that Bacopa might be an effective treatment for Gulf War Illness?

Research has shown that Bacopa monnieri, a herbal supplement, might help improve brain function. Studies have found that Bacopa can boost memory and attention in people with various cognitive challenges. In this trial, participants will receive either BacoMind® 300mg/day or a placebo for 12 weeks. For those with Gulf War Illness, Bacopa could potentially help with memory and thinking problems. Users of Bacopa have reported feeling more mentally clear and focused. While more research is needed specifically for Gulf War Illness, these findings suggest Bacopa could be a promising option for enhancing brain function. ^{1 2 4 6 7}

Who Is on the Research Team?

Amanpreet Cheema, PhD

Principal Investigator

Nova Southeastern Univeristy

Are You a Good Fit for This Trial?

This trial is for Gulf War veterans born between 1946-1974 who served in the theater from Aug 1990 to Jul 1991. They must meet criteria for Gulf War Illness, have stable chronic conditions like hypertension or PTSD, and not require hospitalization recently. Participants should not be heavy drinkers/smokers, pregnant, or have severe organ diseases.

Inclusion Criteria

Able to consent to the study

Participants of childbearing potential must practice effective contraception during the study

Agrees to participate in follow-up visits

Exclusion Criteria

Current heavy alcohol or tobacco use

I have a bleeding disorder or I'm currently using blood thinners, except for low-dose NSAIDs.

Temporary conditions discovered at screening for which participants may be rescreened 6 weeks after resolution of condition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of either BacoMind® Bacopa monnieri extract or placebo

12 weeks

Remote assessments and biweekly monitoring calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Assessments at 16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BacoMind® (Bacopa monnieri standardized extract)
• BACOPA
• Placebo

Trial Overview The study tests Bacopa monnieri extract (BacoMind®) against a placebo to see if it improves cognitive function in patients with Gulf War Illness. It's a phase II trial where participants are randomly assigned to either the supplement group or placebo group without knowing which one they're receiving.

How Is the Trial Designed?

Group I: BacoMind® 300mg/day Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

BacoMind® (Bacopa monnieri standardized extract) is already approved in India, United States for the following indications:

Approved in India as BacoMind for:

• Memory enhancement
• Cognitive function improvement
• Anxiety reduction
• Stress relief

Approved in United States as Bacopa monnieri for:

• Dietary supplement for cognitive support
• Neuroprotection

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Published Research Related to This Trial

Bacopa monnieri (BM) significantly improved short-term memory performance in mice with vascular dementia, indicating its potential as a treatment for cognitive deficits related to cerebral ischemia.

The active compound bacopaside I demonstrated strong neuroprotective effects against cell damage caused by oxygen and glucose deprivation, working through the PKC and PI3K/Akt signaling pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective effects of Bacopa monnieri on ischemia-induced cognitive deficits in mice: the possible contribution of bacopaside I and underlying mechanism. Le, XT., Nguyet Pham, HT., Van Nguyen, T., et al.[2019]

The alcoholic extract of Bacopa monniera was tested in vitro on guinea-pig ileum and showed a dose-dependent reduction in naloxone-induced contractions after morphine exposure, indicating potential for alleviating morphine withdrawal symptoms.

The study suggests that B. monniera may be beneficial in managing withdrawal symptoms from morphine, highlighting its possible therapeutic role in addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcoholic extract of 'Bacopa monniera' reduces the in vitro effects of morphine withdrawal in guinea-pig ileum. Sumathi, T., Nayeem, M., Balakrishna, K., et al.[2019]

Bacopa monnieri extracts significantly inhibit the release of pro-inflammatory cytokines TNF-α and IL-6 from microglial cells, suggesting its potential as an anti-inflammatory agent in the brain.

The study also found that Bacopa extracts effectively inhibit key inflammatory enzymes, such as caspase-1 and caspase-3, which are associated with neuroinflammation and Alzheimer's disease, indicating its promise for treating central nervous system disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ayurvedic plant Bacopa monnieri inhibits inflammatory pathways in the brain. Nemetchek, MD., Stierle, AA., Stierle, DB., et al.[2018]

Bacopa monnieri (BM) demonstrated significant neuroprotective effects in a rat model of autism spectrum disorder (ASD), particularly at a dose of 80 mg/kg, improving social behavior, learning, memory, and motor coordination.

The mechanism of action for BM includes antioxidant and anti-inflammatory properties, as well as modulation of AMPA receptor expression, suggesting it could be a promising treatment for ASD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective effect of the standardised extract of Bacopa monnieri (BacoMind) in valproic acid model of autism spectrum disorder in rats. Abhishek, M., Rubal, S., Rohit, K., et al.[2022]

Bacopa monnieri extract (BME) demonstrated significant neuroprotective effects in a mouse model of Parkinson's disease, improving behavioral parameters and restoring dopamine levels when administered before or after the neurotoxin MPTP.

The study suggests that BME may slow disease progression and delay neurodegeneration in Parkinson's disease by inactivating monoamine oxidase B, which prevents the breakdown of MPTP to its toxic form, MPP+.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective and Neurorescue Mode of Action of Bacopa monnieri (L.) Wettst in 1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine-Induced Parkinson's Disease: An In Silico and In Vivo Study. Singh, B., Pandey, S., Rumman, M., et al.[2021]

Bacopa monnieri (BM) has been shown to effectively relieve acute pain and inflammation by selectively inhibiting the COX-2 enzyme, which reduces inflammatory mediators, making it a promising option for managing pain-related conditions.

In addition to its anti-inflammatory properties, BM may enhance cognitive function over prolonged use (more than 3 months) by regulating chronic inflammation and oxidative stress, suggesting its potential in treating age-related cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacopa monnieri (L.) exerts anti-inflammatory effects on cells of the innate immune system in vitro. Williams, R., Münch, G., Gyengesi, E., et al.[2014]

BacoMind, derived from the medicinal plant Bacopa monniera, was found to be safe and well-tolerated in a study involving 23 healthy adult volunteers over 30 days, with no serious adverse effects reported.

While mild gastrointestinal issues were noted, they resolved on their own, indicating that BacoMind meets safety criteria for short-term use at doses of 300 mg and 450 mg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of BacoMind in healthy volunteers: a phase I study. Pravina, K., Ravindra, KR., Goudar, KS., et al.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04927338

NCT04927338 | Study of Bacopa in Gulf War Illness Patients This phase II, double masked, randomized, placebo-controlled, two-arm study will evaluate cognitive function as evidence of efficacy of the nutraceutical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9189930/

A randomized phase II remote study to assess Bacopa for Gulf ... The goal of this study is to assess the efficacy of a novel low-risk therapeutic agent, Bacopa monnieri, for cognitive function in Veterans with GWI.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04927338/study-of-bacopa-in-gulf-war-illness-patients

Study of Bacopa in Gulf War Illness Patients This phase II, double-masked, randomized, placebo-controlled, two-arm study will focus on assessing cognitive function as evidence of efficacy ...

4. rti.org rti.org/publication/randomized-phase-ii-remote-study-assess-bacopa-gulf-war-illness-associated-cognitive-dysfunction-des

A randomized phase II remote study to assess Bacopa for Gulf ... The goal of this study is to assess the efficacy of a novel low-risk therapeutic agent, Bacopa monnieri, for cognitive function in Veterans with GWI and to ...

5. nova.edu nova.edu/inim/research-studies/gulf-war-illness.html

Gulf War Illness Research Gulf War Illness (GWI) is a chronic condition affecting veterans of the 1990-1991 Persian Gulf War. Join our GWI trial to help find treatments.

6. ctv.veeva.com ctv.veeva.com/study/study-of-bacopa-in-gulf-war-illness-patients

Study of Bacopa in Gulf War Illness Patients Description: Participants randomized to the experimental arm will receive 12 weeks of 300 mg/day BacoMind® Bacopa monnieri standardized extract.

7. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Bacopa_monnieri_UPDATE_%28supplements%29.pdf

Bacopa Monnieri In addition, these reports include evaluation of safety data, from clinical trials if available, and from preclinical models. Bacopa Monnieri.