MemoryNCT03974399
BDNF Levels After Bacopa
A study testing Bacopa Monnieri in people with Memory, run by Roskamp Institute Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory
- What is being tested?
- Bacopa Monnieri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Roskamp Institute, Inc.
Sarasota, Florida, 34243
About this study
Official title: Longitudinal Assessment of BDNF Levels in Healthy Subjects Taking Bacopa Monnieri
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.
Read the 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
- Being tested
- Bacopa Monnieri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacopa MonnieriDietary supplement
subjects will take Bacopa Monnieri daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| study enrollment | Other | all participants will take dietary supplement, Bacopa Monnieri, daily for 3 months Receives: Dietary Supplement: Bacopa Monnieri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brain Derived neurotrophic factor (BDNF)
- Change in BDNF levels
Measured: 3 months
Changes in Brain Derived Neurotropic factor (BDNF) signaling pathway
Change in BDNF signaling pathway
Measured: 3 months
Secondary outcomes (2)
Change in Montreal Cognitive Assessment
Changes in Montreal Cognitive Assessment (MoCA). Score range 0-30.
Measured: 3 months
Change in Geriatric Depression Scale
Change in Geriatric Depression Scale (GDS). Score range 0-15.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start30 May 2019
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roskamp Institute Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Andrew Keegan, M.D., Principal investigator, The Roskamp Institute Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974399
- Sponsor's protocol ID
- RI-Bacopa-001
- Status last verified
- Jun 2019
- First submitted
- 30 May 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of BDNF Levels in Healthy Subjects Taking Bacopa Monnieri
- ClinicalTrials.gov ID
- NCT03974399
- Acronym / sponsor ID
- RI-Bacopa-001
- Conditions
- Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Roskamp Institute Inc.University, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 30 May 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study enrollment | Other | Dietary Supplement: Bacopa Monnieriall participants will take dietary supplement, Bacopa Monnieri, daily for 3 months |
Who may qualify
- Ages
- 60 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacopa Monnierisubjects will take Bacopa Monnieri daily for 3 months | Dietary supplement | study enrollment |
Primary outcome
Changes in Brain Derived neurotrophic factor (BDNF)
Time frame: 3 months
a. Change in BDNF levels
Changes in Brain Derived Neurotropic factor (BDNF) signaling pathway
Time frame: 3 months
Change in BDNF signaling pathway
2 secondary outcomes
Change in Montreal Cognitive Assessment
Time frame: 3 months
Change in Geriatric Depression Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Keegan, M.D. principal investigator
The Roskamp Institute Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacopa Monnieri in people with Memory, run by Roskamp Institute Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Brain Derived neurotrophic factor (BDNF) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.