Efficacy Study of AlphaBRAIN Administered Orally

The manufacturers of AlphaBRAIN(TM) claim that their product, when taken as directed, has beneficial effects on cognition. The active ingredient in AlphaBRAIN, Huperzine A, is a naturally occurring compound found in firmoss and also thought to be an acetylcholinesterase inhibitor. Numerous clinical studies have been undertaken to investigate the effects of Huperzine A on cognition and have demonstrated benefit to cognition in both individuals diagnosed with neurodegenerative diseases as well as performance on academic tasks by students. However, to our knowledge, there are no randomized controlled trials evaluating the effects of AlphaBRAIN(TM) on cognition. Thus, the purpose of the current study is to assess the effects of daily oral administration of AlphaBRAIN(TM) on cognitive functioning, as compared to placebo, after 45 days of treatment.

1. To evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on the change in a battery of standardized neuropsychological tests (see attached). 2. A secondary objective is to evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on sleep.

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Key information

Conditions

Cognitive Functioning

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boston Center for Memory

Chestnut Hill, Massachusetts, 02467, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Community dwelling and can provide informed consent.
MMSE score of ≥ 26.
Body Mass Index within two standard deviations of the norm.
Fluent in English.
Willing to complete all study assessments.
Adequate visual and auditory acuity to allow for neuropsychological testing.

Exclusion criteria

MMSE score < 26
Body Mass Index greater then two standard deviations from the norm.
Visual or Auditory disability which would interfere with neuropsychological testing.
No past diagnosis of Stroke, ADD/ADHD, Learning Disability or Cardiac Condition.
No current life threatening illnesses.
Not currently (past 60 days) taking antidepressants or other psychoactive medications.
Not currently taking any non-prescription cognitive enhancers (nutraceuticals or vitamins such as Ginko biloba.
No history of alcohol or drug or dependence as defined by the DSM-IV-TR.

Treatment and study plan

AlphaBrain

Dietary Supplement

Alpha BRAIN® (Onnit Labs LLC) is a multi-ingredient nutritional supplement that purports to enhance cognitive function in healthy adults. The commercially available product contains 12 naturally occurring compounds

Primary outcomes

Performance on Standardized Neuropsychological Battery (Verbal Memory; Executive Functioning; Visual Memory; Working Memory; Attention; Processing Speed)

Time frame: Six Weeks

Sponsors and collaborators

Lead sponsor

Onnits Labs, LLC

Industry

Registry information

Official study title

Randomized Double-blind, Placebo-Controlled, Parallel Group, Efficacy Study of AlphaBRAIN(TM) Administered Orally

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Apr 15, 2016
Registry last updated: Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed