A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN ® administered orally

Abstract

Background: Alpha BRAIN is a nootropic supplement that purports to enhance cognitive functioning. Several of the naturally occurring compounds in Alpha BRAIN have cholinesterase inhibiting properties and thus could prove beneficial in individuals with subjective memory complains or objective cognitive impairment due to Alzheimer's disease or other cognitive disorders. The goal of this preliminary study was to investigate the efficacy of this self‐described cognitive enhancing nootropic on cognitive functioning in a group of healthy adults by utilizing a randomized, double‐blind, placebo controlled design. Methods: A total of 66‐ treatment naive individuals between 18‐35 years of age participated in the randomized, double‐blind, placebo controlled trial. All participants completed a two‐week placebo run in before receiving active product, Alpha BRAIN or new placebo. Participants then followed the manufactures recommended instructions for use for six weeks. Participants undertook a battery of neuropsychological tests at randomization, (day +15), and again approximately six weeks later at study completion. Primary outcome measures included neuropsychological tests from the WMS‐IV, DKEFS, CVLT‐II, Trails A & B and PSAT as well as measures of wakefulness and dreams. Results: Bivariate analysis indicated no significant differences between groups on any demographic variables and both groups demonstrated excellent supplement adherence (> 90%) and tolerance. Following the two‐week placebo run in, no significant differences were found between groups on any cognitive measure. At six weeks, significant improvement was noted in tasks of delayed verbal recall task and executive functioning for the Alpha BRAIN group compared to placebo (p < .05). Both groups demonstrated overall improvement on neuropsychological tests between time points. Analysis of variance (ANOVA) was utilized to assess the impact of randomization on neuropsychological outcome measures across time points. Results indicated significant interaction effects for improvement in delayed verbal recall for the Alpha BRAINgroup, F (1,61) =4.07, p< .05, partial eta squared =.06. Conclusions: The use of Alpha BRAIN for 6‐weeks significantly improved recent verbal memory when compared with controls, in a group of healthy adults. While the outcome of the study is encouraging, this is the first randomized controlled trial of Alpha BRAIN and the results merit further study. (Table presented).