Effect of a Standardized Extract of Stem (ETAS®50) on Cognitive Function, Psychological Symptoms, and Behavior in Patients with Dementia: A Randomized Crossover Trial.

Dementia is a disease of substantial national concern in a superaging society in Japan. Thus, the treatments targeting this disease are of high priority. However, pharmaceutical treatments are under development and invasive. Hence, many alternative treatments, which are less invasive, are tried, and some of them are supposed to work for dementia symptoms. ETAS®50 is one of these treatments. ETAS®50, a standardized extract of the stem with heat shock protein-inducing activity, is a functional food. ETAS®50 has antistress, autonomic nerve regulation, and sleep quality improvement effects in humans and could contribute to relieving dementia symptoms. This double-blind crossover pilot trial aimed to examine the effects of ETAS®50. A total of 27 patients with mild-to-moderate dementia between October 2018 and February 2020 were included in the trial. ETAS®50 was consumed for 12 weeks and then a placebo for 12 weeks. A significant difference in the mean score of the severity of symptoms in the Neuropsychiatric Inventory Questionnaire (NPI-Q-a) was observed between the ETAS®50 period (0.56 ± 1.72 points) and placebo period (-0.67 ± 2.34 points) (=0.045). Between-group comparisons with respect to the items of NPI-Q-a also showed a significant decrease in symptoms in the ETAS®50 period compared with the placebo period (=0.015 for agitation and =0.045 for depression). In addition, we observed that scores for apathy tended to improve in the ETAS®50 period (=0.058).