Efficacy Study of AlphaBRAIN Administered Orally

Study Overview
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Brief Summary
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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. 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). A secondary objective is to evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on sleep.

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

Conditions
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Cognitive Functioning

Intervention / Treatment
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* Dietary Supplement: AlphaBrain


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: AlphaBrain<br>* 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<br>|
| Experimental: AlphaBrain<br>AlphaBrain(TM) | Dietary Supplement: AlphaBrain<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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