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日本多模式干预预防痴呆症 PRIME 项目(J-MINT PRIME Tamba):一项随机对照多领域干预试验的研究方案。

The Japan-Multimodal Intervention Trial for Prevention of Dementia PRIME Tamba (J-MINT PRIME Tamba): Study protocol of a randomised controlled multi-domain intervention trial.

机构信息

Division of Cognitive and Psychiatric Rehabilitation, Department of Rehabilitation Science, Kobe University Graduate School of Health Sciences, 7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo 654-0142, Japan.

Centre for Preventing Dementia, Kobe University Graduate School of Health Sciences, 7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo 654-0142, Japan; Department of Occupational Therapy, Faculty of Rehabilitation, Kobe Gakuin University, 518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Hyogo 651-2180, Japan.

出版信息

Arch Gerontol Geriatr. 2023 Jan;104:104803. doi: 10.1016/j.archger.2022.104803. Epub 2022 Aug 31.

DOI:10.1016/j.archger.2022.104803
PMID:36088747
Abstract

The Japan-Multimodal Intervention Trial for Prevention of Dementia PRIME Tamba (J-MINT PRIME Tamba) is a randomised controlled trial to prevent cognitive decline in community-dwelling cognitively ordinary older people at risk of dementia. Participants are aged 65-85 years living in a rural area in Japan, aware of very mild decline in cognitive function or abilities of activities of daily living, have at least one vascular risk (e.g. hypertension or diabetes), and have a Mini-Mental State Examination score of 24 or higher. Approximately 200 participants are randomly divided into two groups, with the intervention group receiving a multi-modal intervention, including lifestyle-related disease management, physical exercise, cognitive training, and nutritional counselling, over 18 months. The primary outcome is change in the composite score of seven neuropsychological tests, including the Free and Cued Selective Reminding Test, Logical Memory I and II subsets of the Wechsler Memory Scale-Revised, and Digit Symbol Substitution Test of the Wechsler Adult Intelligence Scale. In addition, changes in a wide range of other parameters such as physical function, blood test results, sleep, and frailty are also analysed as secondary outcomes. We believe that this study's results will contribute significantly to the development of dementia prevention measures in Japan. Clinical trial registration number: UMIN000041938.

摘要

日本多模态干预预防痴呆症前期 Tamba 试验(J-MINT PRIME Tamba)是一项随机对照试验,旨在预防认知功能正常的社区居住的老年痴呆症高危人群认知能力下降。参与者年龄在 65-85 岁之间,居住在日本农村地区,认知功能或日常生活活动能力出现非常轻微下降,至少存在一种血管风险(如高血压或糖尿病),且简易精神状态检查评分在 24 分或以上。大约 200 名参与者被随机分为两组,干预组接受多模态干预,包括与生活方式相关的疾病管理、体育锻炼、认知训练和营养咨询,为期 18 个月。主要结局是七种神经心理学测试综合评分的变化,包括自由和线索选择性提醒测试、韦氏记忆量表修订版逻辑记忆 I 和 II 子集以及韦氏成人智力量表数字符号替代测试。此外,还分析了身体功能、血液检查结果、睡眠和虚弱等广泛的其他参数的变化作为次要结局。我们相信,这项研究的结果将为日本预防痴呆症措施的发展做出重要贡献。临床试验注册号:UMIN000041938。

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