Efficacy Study of AlphaBRAIN Administered Orally

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

Study Overview

• Status: Completed
• Conditions: Cognitive Functioning
• Intervention / Treatment: Dietary supplement: AlphaBrain

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Boston Center for Memory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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
Experimental: AlphaBrain; AlphaBrain(TM)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance on Standardized Neuropsychological Battery (Verbal Memory; Executive Functioning; Visual Memory; Working Memory; Attention; Processing Speed)	Six Weeks

Collaborators and Investigators

• Sponsor: Onnits Labs, LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 25, 2013
• First Submitted That Met QC Criteria: April 10, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 10, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: AB-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No