Efficacy Study of AlphaBRAIN Administered Orally

Cognitive Functioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739139
• Other study ID #: AB-001
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2013
• Last updated: April 10, 2016
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2016
• Source: Onnits Labs, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Functioning

Intervention

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

Locations

Country	Name	City	State
United States	Boston Center for Memory	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Onnits Labs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on Standardized Neuropsychological Battery (Verbal Memory; Executive Functioning; Visual Memory; Working Memory; Attention; Processing Speed)		Six Weeks	No