Cognitive effects of a dietary supplement made from extract of Bacopa monnieri, astaxanthin, phosphatidylserine, and vitamin E in subjects with mild cognitive impairment: a noncomparative, exploratory clinical study

Abstract

A prospective cohort, noncomparative, multicenter trial was conducted to explore the potential of a phytotherapeutic compound, available as a dietary supplement and containing extracts of Bacopa monnieri and Haematococcus pluvialis (astaxanthin) plus phosphatidylserine and vitamin E, in improving cognition in subjects diagnosed with mild cognitive impairment. Enrolled subjects (n=104) were aged 71.2±9.9 years and had a mini-mental state examination score of 26.0±2.0 (mean ± standard deviation). They underwent the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) test and the clock drawing test at baseline and upon completion of a 60-day period of dietary supplementation with one tablet daily of the tested compound. In 102 assessable subjects, total ADAS-cog scores improved from 13.7±5.8 at baseline to 9.7±4.9 on day 60, and the clock drawing test scores improved from 8.5±2.3 to 9.1±1.9. Both changes were statistically significant (P<0.001). Memory tasks were the individual components of ADAS-cog showing the largest improvements. In a multivariate analysis, larger improvements in total ADAS-cog score were associated with less compromised baseline mini-mental state examination scores. Perceived efficacy was rated as excellent or good by 62% of study subjects. The tested compound was well tolerated; one nonserious adverse event was reported in the overall study population, and perceived tolerability was rated excellent or good by 99% of the subjects. In conclusion, dietary supplementation with the tested compound shows potential for counteracting cognitive impairment in subjects with mild cognitive impairment and warrants further investigation in adequately controlled, longer-term studies.

Keywords: ADAS-cog test; Bacopa monnieri; astaxanthin; clock drawing test; dietary supplement; mild cognitive impairment.

Figure 1

Mean ± standard deviation scores of individual ADAS-cog components before and after treatment with Illumina®. Note: Illumina® (Cristalfarma, Milan, Italy). Abbreviations: ADAS-cog, Alzheimer’s Disease Assessment Scale-cognitive subscale; D0, day 0; D60, day 60.