Bacopa for Gulf War Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Amanpreet Cheema, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Trial Summary

What is the purpose of this trial?

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.

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.

What evidence supports the effectiveness of the treatment BacoMind® (Bacopa monnieri) for Gulf War Syndrome?

BacoMind®, a standardized extract of Bacopa monnieri, has shown potential benefits in improving memory and cognitive function, as well as providing neuroprotective effects in conditions like dementia and Parkinson's disease. It also exhibits anti-inflammatory properties, which may help manage symptoms related to chronic inflammation. ^{1 2 3 4 5}

How is the treatment BacoMind® different from other treatments for Gulf War Syndrome?

BacoMind® is unique because it is a standardized extract of Bacopa monnieri, a plant traditionally used in Ayurvedic medicine to enhance memory and reduce inflammation. Unlike other treatments, it may offer neuroprotective benefits and improve cognitive function, which could be particularly beneficial for symptoms associated with Gulf War Syndrome. ^{2 3 4 6 7}

Research Team

Amanpreet Cheema, PhD

Principal Investigator

Nova Southeastern Univeristy

Eligibility Criteria

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

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

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

Trial Timeline

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

Treatment Details

Interventions

• BacoMind® (Bacopa monnieri standardized extract) (Herbal Supplement)
• BACOPA (Herbal Supplement)
• Placebo (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.

Participant Groups

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 for the following indications:

Approved in India as BacoMind for:

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

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Dr. George L. Hanbury II

Nova Southeastern University

Chief Executive Officer since 2011

PhD in Higher Education Administration from Nova Southeastern University

Dr. Gary S. Margules

Nova Southeastern University

Chief Medical Officer since 2010

MD from University of Miami

RTI International

Collaborator

Trials

201

Recruited

942,000+

Dr. Anuja Purohit

RTI International

Chief Medical Officer

MD from Duke University School of Medicine

Tim J. Gabel

RTI International

Chief Executive Officer since 2022

Adjunct appointments at University of Wyoming and UNC Gillings School of Global Public Health

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Sophie Kornowski

Boston University

Chief Executive Officer since 2022

MBA from the University of Chicago, Doctorate in Pharmacy from Paris Descartes University

Dr. Patrizia Cavazzoni

Boston University

Chief Medical Officer

MD from McGill University

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Bacopa monnieri (L.) exerts anti-inflammatory effects on cells of the innate immune system in vitro. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

Safety evaluation of BacoMind in healthy volunteers: a phase I study. [2007]

3. Ireland 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. [2019]

4. Switzerland 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. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Alcoholic extract of 'Bacopa monniera' reduces the in vitro effects of morphine withdrawal in guinea-pig ileum. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

The Ayurvedic plant Bacopa monnieri inhibits inflammatory pathways in the brain. [2018]

7. Ireland 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. [2022]