Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03974399
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2019-05-30
Brief Title:
BDNF Levels After Bacopa
Sponsor:
Roskamp Institute Inc
Organization:
Roskamp Institute Inc
Study Overview
Official Title:
Longitudinal Assessment of BDNF Levels in Healthy Subjects Taking Bacopa Monnieri
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 AEs 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 subjects 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
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 AEs 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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None