BDNF Levels After Bacopa

NCT03974399 | Completed

• 1 other identifier: RI-Bacopa-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Change in Montreal Cognitive Assessment

  3 months

• Change in Geriatric Depression Scale

  3 months

Study Arms (1)

study enrollment

OTHER

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

Dietary Supplement: Bacopa Monnieri

Interventions

Bacopa Monnieri DIETARY_SUPPLEMENT

subjects will take Bacopa Monnieri daily for 3 months

study enrollment

Eligibility Criteria

• Age: 60 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females of any ethnicity, at 60 to 78 on day of screening.
• Have a score of 25 or above on MoCA (Montreal Cognitive assessment).
• Have a score of 9 or below on GDS (Geriatric Depression Scale)
• Provide written informed consent.
• Be able and willing to follow instructions, participate in study assessments, and be present for the required study visits.
• Otherwise stable medical history and general health up to the discrepancy of the PI.

You may not qualify if:

• Have contraindications, allergy, or sensitivity to the study product or their components.
• 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.
• 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).
• 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).
• 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.
• Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within six months of entering this study.

Sponsors & Collaborators

• Roskamp Institute Inc.: lead
• Florida Department of Health: collaborator

Study Sites (1)

The Roskamp Institute, Inc.

Sarasota, Florida, 34243, United States

Location

Study Officials

• Andrew Keegan, M.D.

  The Roskamp Institute Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 4, 2019
• Study Start: May 30, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 2, 2021

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)