Restricted accessResearch articleFirst published online 2025-7
Japan-multimodal intervention trial for the prevention of dementia in older people with lifestyle-related diseases: A community-based,18-month,randomized controlled trial
The prevalence of Alzheimer's disease is increasing in Japan, highlighting the need to establish evidence-based strategies for its prevention.
Objective
We aimed to evaluate the effectiveness of a multimodal community-based intervention for Japanese older people with lifestyle-related diseases and to identify challenges in implementing such interventions to prevent dementia in local communities.
Methods
An 18-month randomized controlled trial was conducted among individuals aged 65–85 years with lifestyle-related diseases (hypertension, hyperlipidemia, diabetes, overweight/underweight, smoking), residing in a single apartment complex. Participants were randomly assigned to a multimodal intervention group (group-based physical exercise, nutritional guidance, management of lifestyle-related diseases, and cognitive training) or a control group. The primary outcome was the change in the composite score derived from seven neuropsychological tests. The trial was registered (UMIN000041887: September 24, 2020).
Results
Of 224 screened individuals, 198 were randomized (99 in each group), and 175 (88.4%) completed the 18-month assessment. There was no significant difference between the intervention and control groups in the primary outcome (change in composite test score: 0.25; 95% confidence interval 0.16 to 0.33 versus 0.29; 95% confidence interval 0.20 to 0.38, respectively; p= 0.463). However, a subgroup analysis of participants with mild cognitive impairment showed a significant intervention effect on changes in logical memory, for both immediate (p = 0.041) and delayed recall tasks (p= 0.043).
Conclusions
This multimodal intervention program demonstrated no effectiveness in mitigating cognitive decline. Further research is needed to develop more effective strategies and to better define target populations.
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