Effects of Ferulic Acid and Angelica archangelica Extract (Feru-guard ®) on Mild Cognitive Impairment: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Prospective Trial

Abstract

We conducted a multicenter, randomized, double-blind, placebo-controlled prospective trial examining a supplement containing ferulic acid and Angelica archangelica extract (Feru-guard ^®) for mild cognitive impairment (MCI). In the intention-to-treat population, Mini-Mental State Examination (MMSE) scores were significantly better at 24 weeks (p = 0.041) in the active group. In the per protocol population, MMSE was significantly better in the active group at 24 weeks (p = 0.008), and mixed effect models for repeated measures (MMRM) showed significant difference (p = 0.016). ADAS-Jcog was significantly better at 24 (p = 0.035) and 48 weeks (p = 0.015) in the active group, and MMRM was significant (p = 0.031). Thus, Feru-guard ^® may be useful for MCI.

Keywords: Angelica archangelica; dementia; dietary supplement; double-blind randomized trial; ferulic acid; mild cognitive impairment.

Fig. 1

Randomization and assignment of study subjects. Please see the text for reasons for exclusion. ITT, intention-to-treat; PP, per protocol.

Fig. 2

Changes in MMSE and ADAS-Jcog scores in the ITT and PP population. a) There was a significant difference in MMSE scores between the active (FG) and placebo groups at 24 weeks in the ITT population (p = 0.041; Mann– Whitney U test). b) There was a significant difference in ADAS-Jcog scores between the active (FG) and placebo groups at 24 weeks (p = 0.035) and 48 weeks (p = 0.015; Mann– Whitney U test) in the PP population. The MMRM analysis also showed a significant between-group difference (p = 0.031). c) There was a significant difference in MMSE scores between the active (FG) and placebo groups at 24 weeks (p = 0.008; Mann– Whitney U test) and the mixed effect model for repeated measures also showed a significant difference (p = 0.016) in the PP population. ADAS-Jcog, Alzheimer’s Disease Assessment Scale-Cognitive Subscale, Japanese version; ITT, intention-to-treat; MMSE, Mini-Mental State Examination; MMRM, mixed effect model for repeated measures, PP, per protocol.