BDNF Levels After Bacopa

Memory Clinical Trial

Official title:

Longitudinal Assessment of BDNF Levels in Healthy Subjects Taking Bacopa Monnieri

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974399
• Other study ID #: RI-Bacopa-001
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2019
• Source: Roskamp Institute Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 78 Years

Eligibility

Inclusion Criteria:

1. Males or females of any ethnicity, at 60 to 78 on day of screening.

2. Have a score of 25 or above on MoCA (Montreal Cognitive assessment).

3. Have a score of 9 or below on GDS (Geriatric Depression Scale)

4. Provide written informed consent.

5. Be able and willing to follow instructions, participate in study assessments, and be present for the required study visits.

6. Otherwise stable medical history and general health up to the discrepancy of the PI.

Exclusion Criteria:

1. Have contraindications, allergy, or sensitivity to the study product or their components.

2. 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.

3. 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).

4. 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).

5. 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.

6. Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within six months of entering this study.

Related Conditions & MeSH terms

• Memory

Intervention

Dietary Supplement:
• Bacopa Monnieri
subjects will take Bacopa Monnieri daily for 3 months

Locations

Country	Name	City	State
United States	The Roskamp Institute, Inc.	Sarasota	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Roskamp Institute Inc.	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Brain Derived neurotrophic factor (BDNF)	a. Change in BDNF levels	3 months
Primary	Changes in Brain Derived Neurotropic factor (BDNF) signaling pathway	Change in BDNF signaling pathway	3 months
Secondary	Change in Montreal Cognitive Assessment	Changes in Montreal Cognitive Assessment (MoCA). Score range 0-30.	3 months
Secondary	Change in Geriatric Depression Scale	Change in Geriatric Depression Scale (GDS). Score range 0-15.	3 months