Takashi Sakurai, 7-430 Morioka, Obu, Aichi, 474-8511, Japan, Tel: +81-562-46-2311, E-mail:
J Prev Alzheimers Dis. 2021;8(4):465-476. doi: 10.14283/jpad.2021.29.
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.
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.
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.
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.
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.
背景/目的：日本多模式干预预防痴呆症试验（J-MINT）旨在通过对痴呆相关生物标志物、组学分析和脑成像分析进行评估，验证多领域干预措施的有效性，并阐明认知改善和恶化的机制。此外，J-MINT 试验与合作的私营企业合作实施相关干预措施。本文描述了研究方案。
设计/设置：为期 18 个月的多中心、随机对照试验。
我们计划招募 500 名年龄在 65-85 岁之间、有轻度认知障碍的老年人。采用全部分层（按年龄、性别和认知分组）的动态分配方法，以 1:1 的比例将受试者中央随机分配到干预组和对照组。
多领域干预方案包括：（1）管理血管危险因素；（2）以小组为基础的身体锻炼和身体活动自我监测；（3）营养咨询；（4）认知训练。对照组每两个月将收到一次健康相关信息。
主要和次要结局将在基线、6、12 和 18 个月随访时进行评估。主要结局是从基线到 18 个月的全球综合评分变化，该评分综合了几个神经心理学领域。次要结局包括：每个神经心理学测试的认知变化、痴呆的发生、血液和痴呆相关生物标志物的变化、包括日常生活活动在内的老年评估的变化、虚弱状态和神经影像学变化，以及服用的药物数量。
这项试验得到了私营企业的支持，将为预防痴呆症创造新的服务，并验证预防痴呆症的多领域干预措施的有效性。
