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BDNF Levels After Bacopa

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ClinicalTrials.gov Identifier: NCT03974399
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Florida Department of Health
Information provided by (Responsible Party):
Roskamp Institute Inc.

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.

Condition or disease Intervention/treatment Phase
Memory Dietary Supplement: Bacopa Monnieri Not Applicable

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


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
study enrollment
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




Primary Outcome Measures :
  1. Changes in Brain Derived neurotrophic factor (BDNF) [ Time Frame: 3 months ]
    a. Change in BDNF levels

  2. Changes in Brain Derived Neurotropic factor (BDNF) signaling pathway [ Time Frame: 3 months ]
    Change in BDNF signaling pathway


Secondary Outcome Measures :
  1. Change in Montreal Cognitive Assessment [ Time Frame: 3 months ]
    Changes in Montreal Cognitive Assessment (MoCA). Score range 0-30.

  2. Change in Geriatric Depression Scale [ Time Frame: 3 months ]
    Change in Geriatric Depression Scale (GDS). Score range 0-15.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Lois Davis, RN, BSN, MA 9412568018 ext 3056 ldavis@roskampinstitute.net
Contact: David Patterson 9412568018 ext 3008 dpatterson@roskampclinic.org

Locations
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United States, Florida
The Roskamp Institute, Inc. Recruiting
Sarasota, Florida, United States, 34243
Contact: Lois Davis    941-256-8018 ext 9412568018    ldavis@roskampinstitute.net   
Contact: Adrienne Scott    9412568018 ext 3007    ascott@roskampclinic.org   
Sponsors and Collaborators
Roskamp Institute Inc.
Florida Department of Health
Investigators
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Principal Investigator: Andrew Keegan, M.D. The Roskamp Institute Inc

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Responsible Party: Roskamp Institute Inc.
ClinicalTrials.gov Identifier: NCT03974399     History of Changes
Other Study ID Numbers: RI-Bacopa-001
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No