J-MINT (Japan)

The Japan Multimodal Intervention Trial for Prevention of Dementia (J-MINT)

J-MINT is the first large-scale randomized controlled trial in Japan to examine the efficacy of lifestyle interventions to prevent cognitive decline. The trial, launched in 2019, investigates the preventive effects of multidomain interventions in older adults with mild cognitive impairment and a high risk of developing dementia. Evidence from the trial is expected to inform national implementation of multidomain intervention programs and support improvements in dementia prevention, medical standards, the medical economy, and societal services.

Locations

The study involves five centers in Obu, Nagoya, Toyoake and Tokyo.

Organizations and collaborators

A multicenter study coordinated by the National Center for Geriatrics and Gerontology (NCGG) with participation from Nagoya University, Nagoya City University, Fujita Health University, and Tokyo Metropolitan Institute for Geriatrics and Gerontology.

The research team collaborated with private companies in delivering the intervention program. This partnership is expected to facilitate the smooth development of new services and manuals following the intervention trials.

Principal Investigator (PI)

Professor Hidenori Arai, National Center for Geriatrics and Gerontology

Research team

Co-PI: Takashi Sakurai, National Center for Geriatrics and Gerontology

Description

Aim
To examine the efficacy of a multidomain intervention program (management of vascular risk factor, physical exercise, nutritional counselling, cognitive training) in reducing cognitive decline among older adults with mild cognitive impairment. Evidence from the trial is expected to inform a large-scale, national implementation of multidomain intervention programs and support further improvements in dementia prevention strategies, medical standards, the medical economy, and societal services.

Duration of the intervention
18 months

Current stage of the project
Complete

Target population
Older adults with mild cognitive impairment aged 65-85 years at high risk of developing dementia

Number of participants
531

Primary outcome
Change in composite score of cognitive function by combining several neuropsychological domains.

Secondary outcomes
include the related changes in physical function, blood biomarkers, brain morphology observed with neuroimaging, and others.

Exploratory outcomes
Cost-effectiveness, factors associated with intervention adherence, identifying populations more likely to benefit from the intervention.

Acknowledgement to funders and collaborators
These studies are supported by the Japan Agency for Medical Research and Development.

Intervention

Domains
Management of vascular risk factors, physical exercise, nutritional counselling, cognitive training.

Results

Primary outcome
No significant mean difference in the change in composite cognitive score from baseline at the 18-month follow-up between the intervention and control groups (mean difference: 0.047; 95% CI −0.029 to 0.124; p = 0.226; Cohen’s d = 0.087).

Secondary outcome
Significant beneficial effects on dietary diversity, number of participating groups, handicap from hearing loss, body mass index, fat-free mass, and systolic blood pressure values at the 18-month follow-up.

Sub-analysis
The adherent intervention group (≥70%) exhibited a significant interventional effect compared to the nonadherent intervention group (mean difference: 0.233; 95% CI 0.079 to 0.388; p = 0.003; Cohen’s d = 0.540) and control group (mean difference: 0.080; 95% CI 0.001 to 0.159; p = 0.047; Cohen’s d = 0.160). A significant interventional effect on the cognitive composite score among older adults with the APOE ε4 allele (mean difference: 0.164; 95% CI 0.011 to 0.317; p = 0.035; Cohen’s d = 0.377) and those with GFAP levels of ≥278.105 pg/mL (mean difference: 0.231; 95% CI 0.009 to 0.453; p = 0.042; Cohen’s d = 0.428).