Efficacy Study of AlphaBRAIN Administered Orally

Onnits Labs

Status and phase

Completed

Phase 2

Conditions

Cognitive Functioning

Treatments

Dietary Supplement: AlphaBrain

Study type

Interventional

Funder types

Industry

Identifiers

NCT02739139

AB-001

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.