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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognitive Functioning Dietary Supplement: AlphaBrain Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-blind, Placebo-Controlled, Parallel Group, Efficacy Study of AlphaBRAIN(TM) Administered Orally
Study Start Date : February 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
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


Outcome Measures
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Primary Outcome Measures :
  1. Performance on Standardized Neuropsychological Battery (Verbal Memory; Executive Functioning; Visual Memory; Working Memory; Attention; Processing Speed) [ Time Frame: Six Weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739139


Locations
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United States, Massachusetts
Boston Center for Memory
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Onnits Labs, LLC
More Information
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Responsible Party: Onnits Labs, LLC
ClinicalTrials.gov Identifier: NCT02739139    
Other Study ID Numbers: AB-001
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016