BDNF Levels After Bacopa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03974399|
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Memory||Dietary Supplement: Bacopa Monnieri||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Longitudinal Assessment of BDNF Levels in Healthy Subjects Taking Bacopa Monnieri|
|Actual Study Start Date :||May 30, 2019|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||June 1, 2020|
all participants will take dietary supplement, Bacopa Monnieri, daily for 3 months
Dietary Supplement: Bacopa Monnieri
subjects will take Bacopa Monnieri daily for 3 months
- Changes in Brain Derived neurotrophic factor (BDNF) [ Time Frame: 3 months ]a. Change in BDNF levels
- Changes in Brain Derived Neurotropic factor (BDNF) signaling pathway [ Time Frame: 3 months ]Change in BDNF signaling pathway
- Change in Montreal Cognitive Assessment [ Time Frame: 3 months ]Changes in Montreal Cognitive Assessment (MoCA). Score range 0-30.
- Change in Geriatric Depression Scale [ Time Frame: 3 months ]Change in Geriatric Depression Scale (GDS). Score range 0-15.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974399
|Contact: Lois Davis, RN, BSN, MA||9412568018 ext email@example.com|
|Contact: David Patterson||9412568018 ext firstname.lastname@example.org|
|United States, Florida|
|The Roskamp Institute, Inc.||Recruiting|
|Sarasota, Florida, United States, 34243|
|Contact: Lois Davis 941-256-8018 ext 9412568018 email@example.com|
|Contact: Adrienne Scott 9412568018 ext 3007 firstname.lastname@example.org|
|Principal Investigator:||Andrew Keegan, M.D.||The Roskamp Institute Inc|