Memory Clinical Trial - BDNF Levels After Bacopa

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Memory

Clinical Trial Details

NCT number	NCT03974399
Study type	Interventional
Source	Roskamp Institute Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 30, 2019
Completion date	June 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01007682` - Intrusive Reexperiencing: The Role of Working Memory Capacity and Thought Suppression	N/A
Completed	`NCT04330677` - Dissecting the Role of Estradiol in Mediating Gender-specific Anxiolytic and Prosocial Effects of Oxytocin	Phase 1
Active, not recruiting	`NCT04392908` - Communication Memory of Cancer Diagnosis Within the Pediatric Triangle
Recruiting	`NCT04694534` - Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients	N/A
Completed	`NCT01159652` - Hypnotic Medications and Memory: Effect of Drug Exposure During the Night	Phase 4
Recruiting	`NCT04598945` - Acquisition and Retention of Motor Memories in Adults and Typically Developing Children	N/A
Terminated	`NCT04021797` - Autonomic Mechanisms of Sleep-dependent Memory Consolidation	N/A
Completed	`NCT04025255` - The Memory and Cognitive Performance Study	N/A
Not yet recruiting	`NCT04103463` - Interactive Stepping Exercise on Memory	N/A
Recruiting	`NCT06351098` - Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition
Completed	`NCT06047899` - Influence of Luteolin for Two Weeks on Memory in Healthy Subjects	N/A
Recruiting	`NCT04402294` - Individualized Closed Loop TMS for Working Memory Enhancement	N/A
Completed	`NCT01126229` - Resveratrol for Improved Performance in the Elderly	Phase 1
Completed	`NCT00913640` - Prospective Memory in Parkinson's Disease
Completed	`NCT01143194` - A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Effects of Three Doses of the Dietary Supplement oréVida™ on Alertness, Attention and Concentration in Healthy Men and Women	Phase 1
Completed	`NCT00454454` - Virtual Reality Helmet to Test for Problems With Memory	N/A
Completed	`NCT00584324` - Depth of Anesthesia on Implicit Memory	N/A
Completed	`NCT06074172` - The Effect of Cannabidiol in Learning and Memory of Adults	Phase 2
Completed	`NCT03763409` - Losartan and Emotional Memory	N/A
Completed	`NCT05907707` - Effects of Gamma-tACS on Memory and Sleep	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.