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Abstract
Desalted Salicornia europaea L. (SE) inhibits acetylcholine esterase, attenuates oxidative stress and inflammatory cytokines, and activates neurotrophic pathway. We performed 12-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy of PhytoMeal(a desalted SE)-ethanol extract (PM-EE), in improving the cognitive performance in patients with subjective memory impairment. 63 participants complaining memory dysfunction without dementia (Korean Mini-Mental State Examination [K-MMSE] score ≥ 23) were assigned to PM-EE 600 mg/day or placebo. The cognitive domain of the Alzheimer's disease assessment scale-Korean version (ADAS-K) was set as the primary outcome. After 12 weeks, there was no differences in the changes in the primary outcome or the frequency of adverse events between the groups. In the subgroup analysis for the 30 subjects with mild cognitive impairment (MCI, baseline K-MMSE scores ≤ 28), PM-EE significantly improved the color-reading score of the Korean color-word stroop test (8.2 ± 25.0 vs. − 4.7 ± 13.2, P = 0.018). Our findings suggest that PM-EE is safe but might not be effective in this setting of this study. However, PM-EE may improve the frontal executive function in the patients with MCI. Further large-sized studies with longer follow-up period is warranted (trial registration number KCT0003418).
Highlights
Dementia is a very prevalent geriatric disorder with a substantial clinical impact[1]
We demonstrated that Acanthoside B regulates cholinergic function by enhancing acetylcholine esterase (AchE) inhibitory activity, attenuates oxidative stress and inflammatory cytokines, and activates the neurotrophic tropomyosin receptor kinase B/cAMP response element binding/brain-derived neurotrophic factor (TrkB/CREB/BDNF) pathway[28], which are all processes involved in the key pathomechanism of both Alzheimer’s disease (AD) and vascular dementia (VD)
In the power analysis for this subgroup, the total number of study subjects required to reach a statistical significance for the effect of PhytoMeal(a desalted SE)-ethanol extract (PM-EE) on the changes in the ADAS-cog score was 566. This is the first randomized controlled study to investigate the effect of PM-EE in subjects complaining memory dysfunction without overt dementia
Summary
Dementia is a very prevalent geriatric disorder with a substantial clinical impact[1]. Recent studies have demonstrated that pathological, functional, and structural changes in the brain begin to develop as early as twenty years before the clinical manifestation of dementia becomes e vident[7]. The early recognition and management of the disease is increasingly being recognized to be crucial to improve the clinical course of d ementia[8,9] In this regard, the clinical attention of the pre-dementia disease stages such as mild cognitive impairment (MCI), a status with objective deficit in cognitive function but without impairment of daily a ctivities[10,11], or subjective memory impairment (SMI), the pre-MCI status that presents with a subjective complaint of memory dysfunction with no clinical evidence of deficit in memory or other cognitive functions[18], are rapidly increasing. We hypothesized that the use of PhytoMeal(a desalted SE)-ethanol extract (PM-EE), would be safe and more effective than placebo in improving cognitive performance in patients who are complaining memory impairment but without dementia and performed a randomized placebo controlled clinical trial to evaluate the efficacy and safety of PM-EE
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