AT AAIC 2015

WASHINGTON (FRONTLINE MEDICAL NEWS) – A randomized, double-blind, placebo-controlled trial has supported the purported cognitive boosting capability of the dietary supplement Alpha BRAIN. While the trial was small, it’s a start, and lends credence to the cognitive boost claimed by the commercially available pills.

“From a science and medicine standpoint, we felt this was an interesting study, both because it would allow us to examine if Alpha BRAIN was indeed efficacious as a cognitive enhancer, and also due to the complete dearth of rigorous scientific and methodologically sound studies that have been performed on similar supplements to date,” principal investigator Todd Solomon, Ph.D. , of Boston University, said in an email.

At the Alzheimer’s Association International Conference 2015, Dr. Solomon presented a study of 63 participants aged 18-35 years who had a 2-week placebo run-in before 30 were double-blind randomized to Alpha BRAIN (Onnit Labs, Austin, Tex.) and 33 to placebo. A battery of neuropsychological tests (Wechsler Memory Scale–Fourth Edition, Delis-Kaplan Executive Function System, California Verbal Learning Test-Second Edition, Trail Making Test parts A and B, and Paced Auditory Serial Addition Test) was run before and at the end of the 6-week study. The two groups were similar at baseline demographically concerning age, estimated IQ, gender, level of education (the majority were currently enrolled college students), and race (most were white). Nearly everyone followed the manufacturer’s instructions, with over 90% in each group taking the real or placebo preparation on schedule for the 6 weeks.

At baseline, both groups were similar in all the cognitive measures. Four participants in the Alpha BRAIN arm and three in the placebo arm dropped out during the next 6 weeks. At trial’s end, both groups showed neuropsychological improvements. Those randomized to receive Alpha BRAIN were significantly better on tasks of delayed verbal recall (P = .01) and executive functioning (P = .05), compared with placebo.

The results are “encouraging,” Dr. Solomon said. Still, the small number of subjects and the brevity of the trial rule out solid conclusions. That will come with similarly designed trials that involve more subjects and run longer.

“As supplements in the United States are not regulated by any governing body, we felt it was important to support a company that was willing to hold themselves to the same type of standards promoted by the Food and Drug Administration for testing the efficacy of experimental compounds,” Dr. Solomon said in an email.

Onnit Labs funded the study. Dr. Solomon had no disclosures. One coauthor is an employee of Onnit Labs, the maker of Alpha BRAIN.

cnnews@frontlinemedcom.com

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