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T. Sugimoto, T. Sakurai, H. Akatsu, T. Doi, Y. Fujiwara, A. Hirakawa, F. Kinoshita, M. Kuzuya, S. Lee, K. Matsuo, M. Michikawa, S. Ogawa, R. Otsuka, K. Sato, H. Shimada, H. Suzuki, H. Suzuki, H. Takechi, S. Takeda, H. Umegaki, S. Wakayama, H. Arai, On behalf of the J-MINT investigators

J Prev Alz Dis 2021;4(8):465-476

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.

T. Sugimoto ; T. Sakurai ; H. Akatsu ; T. Doi ; Y. Fujiwara ; A. Hirakawa ; F. Kinoshita ; M. Kuzuya ; S. Lee ; K. Matsuo ; M. Michikawa ; S. Ogawa ; R. Otsuka ; K. Sato ; H. Shimada ; H. Suzuki ; H. Suzuki ; H. Takechi ; S. Takeda ; H. Umegaki ; S. Wakayama ; H. Arai (2021): The Japan-Multimodal Intervention Trial for Prevention of Dementia (J-MINT): The Study Protocol for an 18-Month, Multicenter, Randomized, Controlled Trial. The Journal of Prevention of Alzheimer’s Disease (JPAD).

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