Efficacy Study of AlphaBRAIN Administered Orally

NCT02739139 | Completed Phase 2

• 1 other identifier: AB-001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Functioning

Outcome Measures

Primary Outcomes (1)

• Performance on Standardized Neuropsychological Battery (Verbal Memory; Executive Functioning; Visual Memory; Working Memory; Attention; Processing Speed)

  Six Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: AlphaBrain

AlphaBrain

EXPERIMENTAL

AlphaBrain(TM)

Dietary Supplement: AlphaBrain

Interventions

AlphaBrain DIETARY_SUPPLEMENT

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

AlphaBrain; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onnits Labs, LLC: lead

Study Sites (1)

Boston Center for Memory

Chestnut Hill, Massachusetts, 02467, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: April 15, 2016
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

US (1)