The Japan-Multimodal Intervention Trial for Prevention of Dementia (J-MINT): The Study Protocol for an 18-Month, Multicenter, Randomized, Controlled Trial

Abstract

Background/Objectives: The Japan-multimodal intervention trial for prevention of dementia (J-MINT) is intended to verify the effectiveness of multi-domain interventions and to clarify the mechanism of cognitive improvement and deterioration by carrying out assessment of dementia-related biomarkers, omics analysis and brain imaging analysis among older adults at high risk of dementia. Moreover, the J-MINT trial collaborates with partnering private enterprises in the implementation of relevant interventional measures. This manuscript describes the study protocol. Design/Setting: Eighteen-month, multi-centered, randomized controlled trial. Participants: We plan to recruit 500 older adults aged 65-85 years with mild cognitive impairment. Subjects will be centrally randomized into intervention and control groups at a 1:1 allocation ratio using the dynamic allocation method with all subjects stratified by age, sex, and cognition. Intervention: The multi-domain intervention program includes: (1) management of vascular risk factors; (2) group-based physical exercise and self-monitoring of physical activity; (3) nutritional counseling; and (4) cognitive training. Health-related information will be provided to the control group every two months. Measurements: The primary and secondary outcomes will be assessed at baseline, 6-, 12-, and 18-month follow-up. The primary outcome is the change from baseline to 18 months in a global composite score combining several neuropsychological domains. Secondary outcomes include: cognitive change in each neuropsychological test, incident dementia, changes in blood and dementia-related biomarkers, changes in geriatric assessment including activities of daily living, frailty status and neuroimaging, and number of medications taken. Conclusions: This trial that enlist the support of private enterprises will lead to the creation of new services for dementia prevention as well as to verify the effectiveness of multi-domain interventions for dementia prevention.

Effects of Eligibility Criteria on Patient Selection and Treatment Implications from 10 Multidomain Dementia Prevention Trials: A Population-Based Study

“…Among 1,655 screened abstracts, we identified five completed and published dementia prevention trials with at least 500 community-dwelling persons: the Dose Responses to Exercise Training (DR's EXTRA) Study published in 2010 [20], the Finnish Geriatric Intervention Neuroepidemiology 2023;57:14-24 DOI: 10.1159/000528120 Study to Prevent Cognitive Impairment and Disability (FINGER) trial in 2015 [5], the Prevention of Dementia by Intensive Vascular care (preDIVA) trial in 2016 [4], the Multidomain Alzheimer Preventive Trial (MAPT) in 2017 [2], and the Healthy Ageing Through Internet Counselling in the Elderly (HATICE) trial in 2019. From grey literature and clinical trial registries, we additionally included another five trials that are ongoing at the time of the search: the US Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (US-POINTER), a randomized controlled trial for Multimodal Intervention to Delay Dementia and Disability in China (MIND-CHI-NA), Maintain Your Brain-Trial (MYB), AgeWell.de, and the Japan-Multimodal Intervention Trial for Prevention of Dementia (J-Mint) [21][22][23][24][25]. A flowchart leading to the included studies is presented in online supplementary eFigure1.…”

“…Half of the dementia prevention trials that were included in this study were specifically designed to recruit a sample of persons at high risk of dementia based on the presence of cardiovascular risk factors [2,5,21,23,25]. Other trials used a more pragmatic design, with few inclusion criteria and enrolment based on age cut-offs, such as DR's EXTRA and preDIVA (also see online suppl.…”

Psychological Resilience Among Older Japanese Adults With Mild Cognitive Impairment During the COVID-19 Pandemic

“…We recruited all participants from the Japan-multimodal intervention trial for prevention of dementia (J-MINT) conducted by the National Center for Geriatrics and Gerontology (NCGG) in Aichi Prefecture (22). The inclusion criterion of this study was older adults with MCI in the age group of 65-85 years.…”

From Dementia to Eumentia: A New Approach to Dementia Prevention

“…The potential long-term effects of multidomain interventions, particularly in those with lower baseline cognitive functioning, urge an extended follow-up for dementia occurrence [16]. The Japan-Multimodal Intervention Trial for Prevention of Dementia (J-MINT) [17] and the SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) [18] are two randomized controlled trials aiming at studying the effectiveness of multidomain lifestyle interventions against dementia in regions where the age-standardized dementia incidence rate has increased during the last three decades. Likewise, the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), the European Prevention of Alzheimer’s Dementia initiative, and some others are also aiming at improving general awareness and studying the dementia prevention potential for multidomain interventions in different populations and regions with varying lifestyles.…”