- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03974399
BDNF Levels After Bacopa
Longitudinal Assessment of BDNF Levels in Healthy Subjects Taking Bacopa Monnieri
Study Overview
Detailed Description
This is a single site two-visit, 12-week, open label, trial to evaluate the safety, tolerability, and potential effects of Bacopa on BDNF, MoCA and GDS. Potentially eligible subjects will be invited to screening (Visit 1) at the study site. Subjects will sign an informed consent followed by collection of medical history and history of current medications, have their height, weight, vital signs (blood pressure, pulse, and temperature) measured, complete study assessments (MoCA , BDS and LEC) Routine clinical laboratory tests (hematology and chemistry) will be performed. Blood samples will be taken for analysis of BDNF and genetics (APOE, BDNF).
Subjects will be instructed to orally self-administer the provided supplement (Bacopa) preferably with food with no dietary restrictions once a day in the morning.
Subjects will be contacted by phone at 1 week (+/- 3 days) to be reminded to go to two pills per day, 1 month (+/-1 week) to check on compliance or any AE's and 2 months (+/- 1 week) to report any Adverse events for review by the Principal Investigator.
Subjects will return to the study site for Visit 2 at the end of 12 weeks (+/- 1 week). Study staff will question subjects about any changes in the subject's health since the first visit. They will be asked about their exercise activity and if there have been any changes to their LEC-5. Subjects will have their weight and vital signs measured. Routine clinical laboratory tests (hematology and chemistry) will be performed, and blood samples will be saved for analysis of Bacopa and other biomarkers
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Sarasota, Florida, United States, 34243
- The Roskamp Institute, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females of any ethnicity, at 60 to 78 on day of screening.
- Have a score of 25 or above on MoCA (Montreal Cognitive assessment).
- Have a score of 9 or below on GDS (Geriatric Depression Scale)
- Provide written informed consent.
- Be able and willing to follow instructions, participate in study assessments, and be present for the required study visits.
- Otherwise stable medical history and general health up to the discrepancy of the PI.
Exclusion Criteria:
- Have contraindications, allergy, or sensitivity to the study product or their components.
- Have any significant illness or condition that could, in the Investigator's or sub-Investigator's opinion, be expected to interfere with the study parameters or study conduct or put the subject at significant risk. These may include but are not limited to: untreated chronic hypertension; receiving chemotherapy; depression requiring medical intervention on a daily basis; myocardial infarction within six months of screening; renal failure; and/or hepatic failure.
- Have a current unstable medical condition (e.g., symptomatic uncontrolled diabetes mellitus), or a condition that might affect their ability to participate (e.g., cancer requiring frequent medical visits for chemotherapy).
- Have values on standard clinical laboratory assessments that are deemed medically significant (show evidence of untreated significant medical illness or pose a risk of significant intercurrent illness during the study in the opinion of the investigator).
- Currently taking any medication classified by the FDA as an anti-depressant or have discontinued one of these types of medications within 30 days of screening.
- Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within six months of entering this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: study enrollment
all participants will take dietary supplement, Bacopa Monnieri, daily for 3 months
|
subjects will take Bacopa Monnieri daily for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Brain Derived neurotrophic factor (BDNF)
Time Frame: 3 months
|
a. Change in BDNF levels
|
3 months
|
Changes in Brain Derived Neurotropic factor (BDNF) signaling pathway
Time Frame: 3 months
|
Change in BDNF signaling pathway
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Montreal Cognitive Assessment
Time Frame: 3 months
|
Changes in Montreal Cognitive Assessment (MoCA).
Score range 0-30.
|
3 months
|
Change in Geriatric Depression Scale
Time Frame: 3 months
|
Change in Geriatric Depression Scale (GDS).
Score range 0-15.
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew Keegan, M.D., The Roskamp Institute Inc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- RI-Bacopa-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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