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NCT04025255 · ClinicalTrials.gov registry record · NA
The Memory and Cognitive Performance Study
A NA study of Cognitive Function and Memory, sponsored by Vita Naturel.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT04025255: Completed NA study of Cognitive Function and Memory, sponsored by Vita Naturel.
NCT04025255 is a NA study of Cognitive Function and Memory that has completed, run by Vita Naturel. The registered enrollment target is 74 participants, below the 494-participant average among 20 other Cognitive Function trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04025255, a NA study of Cognitive Function and Memory, has completed, sponsored by Vita Naturel.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this study is to evaluate the impact of a novel, neuro-protective and neuro-restorative dietary supplement (Braini®) on standardized memory and cognitive performance parameters. The principal active ingredients in the Braini® supplement have been commercially-available since at least 2015 or have achieved FDA new dietary ingredient notification (NDIN) in 2018, with no adverse events reported to the FDA. A 28-day randomized, double-blinded, placebo-controlled dietary supplement study will be conducted with a cohort of younger and a cohort of colder adults to achieve the purpose of this study. The research team hypothesizes that Braini® will improve standardized performance scores measured by CNS Vital Signs standard memory and cognitive performance assays more effectively than placebo.
Primary Outcome
The CNS Vital Signs test is a computerized neuropsychological battery that includes seven sub-tests designed to screen cognitive abilities. The Verbal Memory Test involves immediate and delayed recognition for words presented on the screen. The Visual Memory Test involves immediate and delayed recognition of geometric figures. The Finger Tapping Test involves rapidly press the space bar. The Symbol Digit Coding Test involves typing numbers that correspond to different symbols presented on screen
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Braini
Study Locations (1)
North Carolina
- University of North Carolina at Asheville - Asheville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2020-04-30 |
| Phase | NA |
What the finished NCT04025255 record still lists
NCT04025255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 494-participant average among 20 other Cognitive Function trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with Cognitive Function appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04025255 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04025255 about?
NCT04025255 is a clinical study titled "The Memory and Cognitive Performance Study". The primary purpose of this study is to evaluate the impact of a novel, neuro-protective and neuro-restorative dietary supplement (Braini®) on standardized memory and cognitive performance parameters. The principal active ingredients in the Braini® supplement have been commercially-available since a...
What is the current status of trial NCT04025255?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2019-10-01. Estimated completion is 2020-04-30.
What conditions does trial NCT04025255 study?
This clinical trial studies the following conditions: Cognitive Function, Memory, Brain Health.
What interventions are being tested in trial NCT04025255?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Braini (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04025255?
This trial is sponsored by Vita Naturel, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04025255 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04025255's enrollment target sits among peer trials
74 9th of 20 higher than 12 of 20 other Cognitive Function trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cognitive Function trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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