- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04927338
Study of Bacopa in Gulf War Illness Patients
Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Karen Kesler, PhD
- Phone Number: 919-485-1429
- Email: kkesler@rti.org
Study Contact Backup
- Name: Mayra Vidro, MPH
- Phone Number: 954-262-2841
- Email: mvidro@nova.edu
Study Locations
-
-
Florida
-
Davie, Florida, United States, 33314
- Recruiting
- Nova Southeastern University
-
Contact:
- Amanpreet Cheema, PhD
- Phone Number: (954) 262-2871
- Email: acheema@nova.edu
-
Contact:
- Mayra Vidro, MPH
- Phone Number: 954-262-2841
- Email: mvidro@nova.edu
-
Sub-Investigator:
- Nancy Klimas, MD
-
Sub-Investigator:
- Kristina Aenlle, PhD
-
Principal Investigator:
- Amanpreet Cheema, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Born in years 1946 to1974
- 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.
Exclusion Criteria:
- 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.
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)
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
- 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,
- Use of Bacopa within 6 weeks prior to the enrollment in this study,
- Diagnosed bleeding disorder or current use of anticoagulants and/or antiplatelets, except for low dose nonsteroidal anti-inflammatories (NSAIDS).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BacoMind® 300mg/day
Participants randomized to the experimental arm will receive 12 weeks of 300 mg/day BacoMind® Bacopa monnieri standardized extract.
|
BacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.
Other Names:
|
Placebo Comparator: Placebo
Participants randomized to the placebo arm will receive 12 weeks of daily placebo identical to the experimental treatment in size, color, and shape.
|
Daily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
California Verbal Learning Test (CVLT-II) Assessment
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Biomarker Concentrations
Time Frame: 12 weeks
|
Putative biomarkers 18-plex cytokines, glutamate, brain-derived neurotrophic factor (BDNF), and neurofilament light chain (NfL) will be measured from blood drawn at baseline from all participants and then at 12 weeks from a subgroup of participants.
Differences in the mean concentrations of each of the biomarkers will be assessed at the end of the intervention period in the 12 week blood draw subgroup.
|
12 weeks
|
Veterans RAND 36 Item Health Survey (VR-36©)
Time Frame: 12 weeks
|
Change in mean VR-36 physical component score from baseline to 12 weeks.
Normed values of the VR-36 physical component score (PCS) will be used based on US population estimates.
The minimum score is 0 and the maximum score is 100.
A higher score indicates better health outcomes.
|
12 weeks
|
Veterans RAND 36 Item Health Survey (VR-36©)
Time Frame: 16 weeks
|
Change in mean VR-36 physical component score (PCS) from 12 weeks to 16 weeks.
Normed values of the VR-36 PCS will be used based on US population estimates.
The minimum score is 0 and the maximum score is 100.
A higher score indicates better health outcomes.
|
16 weeks
|
Review of Treatment Related Adverse Events
Time Frame: 16 weeks
|
Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.
|
16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amanpreet Cheema, PhD, Nova Southeastern Univeristy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GWICTIC-Bacopa
- W81XWH1820062 (Other Grant/Funding Number: US DoD USAMRAA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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