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Efficacy Study of AlphaBRAIN Administered Orally

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02739139
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Onnits Labs, LLC

Tracking Information
First Submitted Date  ICMJE September 25, 2013
First Posted Date  ICMJE April 15, 2016
Last Update Posted Date April 15, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2016)
Performance on Standardized Neuropsychological Battery (Verbal Memory; Executive Functioning; Visual Memory; Working Memory; Attention; Processing Speed) [ Time Frame: Six Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of AlphaBRAIN Administered Orally
Official Title  ICMJE Randomized Double-blind, Placebo-Controlled, Parallel Group, Efficacy Study of AlphaBRAIN(TM) Administered Orally
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cognitive Functioning
Intervention  ICMJE 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: AlphaBrain
  • Experimental: AlphaBrain
    AlphaBrain(TM)
    Intervention: Dietary Supplement: AlphaBrain
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2016)
73
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02739139
Other Study ID Numbers  ICMJE AB-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Onnits Labs, LLC
Study Sponsor  ICMJE Onnits Labs, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Onnits Labs, LLC
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP