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| Name | Class |
|---|---|
| Florida Department of Health | OTHER_GOV |
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Brain-derived neurotrophic factor (BDNF) is a well-known neurotrophic factor important for learning, memory, and synaptogenesis. Healthy activities such as exercise are believed to raise BDNF, while stress is associated with lower BDNF. What is not well understood is if there are certain supplements that may raise BDNF over time. Bacopa monnieri is well characterized nutraceutical. Animal and pre-clinical data support multiple beneficial mechanisms, including raising BDNF and increasing synaptogenesis. Additionally, small studies have shown Bacopa enhances cognition and improves mood. We would like to investigate if BDNF level changes in people after starting Bacopa.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study enrollment | Other | all participants will take dietary supplement, Bacopa Monnieri, daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacopa Monnieri | Dietary Supplement | subjects will take Bacopa Monnieri daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Brain Derived neurotrophic factor (BDNF) | a. Change in BDNF levels | 3 months |
| Changes in Brain Derived Neurotropic factor (BDNF) signaling pathway | Change in BDNF signaling pathway | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montreal Cognitive Assessment | Changes in Montreal Cognitive Assessment (MoCA). Score range 0-30. | 3 months |
| Change in Geriatric Depression Scale | Change in Geriatric Depression Scale (GDS). Score range 0-15. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Keegan, M.D. | The Roskamp Institute Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Roskamp Institute, Inc. | Sarasota | Florida | 34243 | United States |
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| 3 months |