TY - JOUR
T1 - The Japan-Multimodal Intervention Trial for Prevention of Dementia (J-MINT)
T2 - The Study Protocol for an 18-Month, Multicenter, Randomized, Controlled Trial
AU - J-MINT investigators
AU - Sugimoto, T.
AU - Sakurai, Takashi
AU - Akatsu, H.
AU - Doi, T.
AU - Fujiwara, Y.
AU - Hirakawa, A.
AU - Kinoshita, F.
AU - Kuzuya, M.
AU - Lee, S.
AU - Matsuo, K.
AU - Michikawa, M.
AU - Ogawa, S.
AU - Otsuka, R.
AU - Sato, K.
AU - Shimada, H.
AU - Suzuki, H.
AU - Suzuki, H.
AU - Takechi, H.
AU - Takeda, S.
AU - Umegaki, H.
AU - Wakayama, S.
AU - Arai, H.
N1 - Publisher Copyright:
© 2021, Serdi and Springer Nature Switzerland AG.
PY - 2021/9
Y1 - 2021/9
N2 - 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.
AB - 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.
KW - Cognitive decline
KW - cognitive training
KW - multidomain intervention
KW - nutrition
KW - physical exercise
UR - http://www.scopus.com/inward/record.url?scp=85107594796&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85107594796&partnerID=8YFLogxK
U2 - 10.14283/jpad.2021.29
DO - 10.14283/jpad.2021.29
M3 - Article
C2 - 34585222
AN - SCOPUS:85107594796
SN - 2426-0266
VL - 8
SP - 465
EP - 476
JO - The journal of prevention of Alzheimer's disease
JF - The journal of prevention of Alzheimer's disease
IS - 4
ER -
