Effects of an 18-month multimodal intervention on cognitive function (J-MINT PRIME Tamba): A randomized controlled trial

Hisatomo Kowa, Kobe University Graduate School of Health Sciences, Kobe, Japan
Yutaro Oki, Kobe University Graduate School of Health Sciences, Kobe, Japan
Tohmi Osaki, Kobe Gakuin University, Kobe, Japan
Ryoko Kugamai, Kobe University Graduate School of Health Sciences, Kobe, Japan


In recent years, the effectiveness of multimodal intervention in dementia prevention has attracted attention, and several randomized controlled trials (RCTs) have been reported, beginning with the FINGER study. However, there is no consensus on the effectiveness of multidisciplinary interventions, and generalizing strategies to prevent cognitive impairment and dementia is challenging. This study aims to conduct an RCT to examine the efficacy of a multi-domain dementia prevention program, which consists of lifestyle-related disease management, physical exercise, nutrition counseling, and cognitive training on improving or maintaining cognitive function or reducing cognitive decline in older Japanese people at risk for dementia. The change of brain function by multimodal intervention was examined by digital devices in this study.

Participants and Methods:

A randomized controlled trial (Japan-Multimodal Intervention Trial for Prevention of Dementia PRIME Tamba; J-MINT PRIME Tamba) was conducted to prevent cognitive decline in community-dwelling older people at risk of dementia [3]. Between Sep 2020, and Oct 2020, we screened 206 individuals and randomly assigned 203 participants (male: 57, mean age: 73.86±4.84, mean MMSE score: 28.65±1.36) were randomly assigned to the intervention group (101 participants) or the control group (102 participants). The intervention group received 90 minutes of group-based physical exercise weekly, cognitive training, nutritional counseling, and vascular risk factor management for 18 months (78 sessions total). Reaction speed, attention, visual learning, and memory scores were measured twice, once at baseline and again 18 months after the intervention using the Eisai KNOW (Eisai Co., Ltd.), the Japanese version of the Cognigram by the Cogstate. Statistical analyses were performed using a linear mixed-effects model with a Per Protocol Set that excluded missing initial data at a significance level of less than 5%.


One hundred and ninety-nine subjects (99 in the intervention group vs. 100 in the control group) were included in the analysis after exclusion of missing initial data, and statistically significant differences were found in reaction time (101.62±7.07 vs. 98.63±9.75, p<0.01) and attention (100.19±7.19 vs. 98.16±7.56, p=0.02) at the 18-month measurement. The differences were statistically significant for visual learning (100.26±7.01) and attention (100.19±7.19 vs. On the other hand, no statistically significant differences were found in visual learning (100.26±13.26 vs. 98.63±13.71, p=0.89) and memory (98.99±8.13 vs. 96.71±7.39, p=0.29).


An 18-month, non-pharmacologic, multifactorial intervention for cognitively normal older adults living in areas at risk for dementia was shown to improve reaction time and attention on the KNOW, a digital device-based assessment of brain function.

Category: Cognitive Intervention/Rehabilitation

Keyword 1: clinical trials
Keyword 2: cognitive rehabilitation