薬理と治療

Abstract

Objective　This study evaluated the effect of consuming NO-NAI-KAKUSAN, a nucleic acid-containing food, for 12 weeks on cognitive function in Japanese adults with memory decline. Methods　A randomized, placebo-controlled, double-blind, parallel-group comparison study was conducted from November 2020 to May 2021 in healthy Japanese adults aged ≥40 years. First, a computer was used to randomly but equally assign 66 subjects who met the eligibility criteria to the NO-NAI-KAKUSAN or placebo group. Then, eight NO-NAI-KAKUSAN or placebo tablets were administered daily for 12 weeks. The primary outcome was composite memory from the Cognitrax cognitive test, and the secondary outcomes were other cognitive functions and subjective symptoms for memory. We also conducted a safety assessment during the intervention period. Results　Per-protocol data set was used for efficacy analysis. Each group included 30 subjects （the NO-NAI-KAKUSAN group, 54.2±8.0 years, and the placebo group, 54.2±7.5 years）.The standardized score of composite memory and verbal memory after the 12-week intervention was significantly higher in the NO-NAI-KAKUSAN group than in the placebo group（P＝0.045, P＝0.049, respectively）. There were no clinical adverse events due to food intake. Conclusions　The results indicated that consuming NO-NAI-KAKUSAN improved the memory of healthy Japanese adults aged 40 years or older who experienced memory decline. Trial registration　UMIN000042446 Foundation　MAINICHIGENKI. CO., LTD.