BDNF Levels After Bacopa

Completed · Not applicable

Conditions studied: Memory

In brief

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.

Key facts

Study ID

NCT03974399

Run by

Roskamp Institute Inc.

People needed

44

Starts

2019-05-30

Expected to finish

2020-06-01

Last updated by the study team

2021-03-02

Who can join

Age: 60 and older, up to 78. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• The Roskamp Institute, Inc. — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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