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

作者：Taiki Sugimoto, Takashi Sakurai, Hiroyasu Akatsu, Takehiko Doi, Yoshinori Fujiwara, Akihiro Hirakawa, Fumie Kinoshita, Masafumi Kuzuya, S. Lee, Koichiro Matsuo, Makoto Michikawa, Susumu Ogawa, Rei Otsuka, Kenji Sato, Hiroyuki Shimada, Hiroyuki Suzuki, Hiroyuki Suzuki, Hajime Takechi, Shinya Takeda, Hiroyuki Umegaki, Satomu Wakayama, Hidenori Arai · 发表于：The Journal of Prevention of Alzheimer s Disease · 年份：2021 · DOI：10.14283/jpad.2021.29 · 被引用次数：43 · 研究领域：Dementia and Cognitive Impairment Research、Older Adults Driving Studies、Nutrition and Health in Aging

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 domain...