BDNF Levels After Bacopa

NCT ID: NCT03974399

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2020-06-01

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 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

Conditions

Memory

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

study enrollment

all participants will take dietary supplement, Bacopa Monnieri, daily for 3 months

Group Type: OTHER

Bacopa Monnieri

Intervention Type: DIETARY_SUPPLEMENT

subjects will take Bacopa Monnieri daily for 3 months

Interventions

Bacopa Monnieri

subjects will take Bacopa Monnieri daily for 3 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida Department of Health

OTHER_GOV

Sponsor Role: collaborator

Roskamp Institute Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Keegan, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Roskamp Institute Inc

Locations

The Roskamp Institute, Inc.

Sarasota, Florida, United States

Countries

United States

Other Identifiers

RI-Bacopa-001

Identifier Type: -

Identifier Source: org_study_id