NCT02739139

Efficacy Study of AlphaBRAIN Administered Orally

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Onnits Labs, LLC · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cognitive Functioning

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AlphaBrain	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

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2016-04-15
• Last updated: 2016-04-15

Locations

1 site across 1 country: United States