Unique ID issued by UMIN | UMIN000038671 |
---|---|
Receipt number | R000044075 |
Scientific Title | Japan-multimodal intervention Trial for prevention of dementia (J-MINT) |
Date of disclosure of the study information | 2019/11/25 |
Last modified on | 2021/11/30 08:33:56 |
Japan-multimodal intervention Trial for prevention of dementia (J-MINT)
J-MINT study
Japan-multimodal intervention Trial for prevention of dementia (J-MINT)
J-MINT study
Japan |
Older adults with cognitive impairment.
Geriatrics |
Others
YES
The aim of this study is to identify whether a multidomain intervention incluing management of lifestyle-related disease, exercise, nutritional guidance, and cognitive training could prevent the progression of cognitive decline in older adults with cognitive impairment.
Efficacy
Confirmatory
Pragmatic
Not applicable
Change in a composite score of cognitive function from baseline to a 18-month follow-up.
1) Changes in a composite score of cognitive tests from baseline to a 6/12-month follow-up.
2) Changes in scores of each cognitive test from baseline to a 6/12/18-month follow-up.
3) Changes in laboratory and urinary markers from baseline to a 6/18-month follow-up.
4) Changes in ADL scores from baseline to a 6/18-month follow-up.
5) Changes in the status of frailty from baseline to a 6/18-month follow-up.
6) Changes in brain images assessed using MRI or CT from baseline to a 18-month follow-up.
7) Changes in the number of medications.
8) Changes in each result of a comprehensive geriatric assement from baseline to a 6/18-month follow-up.
9) Incident dementia.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Behavior,custom |
Multidomain intervention including the magement of lifestyle-related disease, exercise, nutritional guidance, and cognitive training.
Diabetes, hypertension, and dyslipidemia will be treated according to the relevant clinical guidelines in Japan.
A 90-minutes multicomponent exercise program, including stretch, muscle strength training, aerobic exercise, exercise with dual task, and behavior modification, will be provided once a week during a 18-month intervention period.
A nutritional counseling using the meeting and telephone interview will be provided 15 times in total.
A cognitive training game named "Brain HQ" will be provided by using iPad.
Usual care.
Providing documents regarding lifestyle and behaviors for the prevention of dementia.
65 | years-old | <= |
86 | years-old | > |
Male and Female
Subjects who
1) aged 65-85 at the time of enrollment.
2) have age-adjusted decline at least SD of 1.0 from the reference threshold in any cognitive domains measured by using NCGG-FAT.
3) have provided a written informed consent on this study and biobank project* by subjects.
*: Only for subjects recruited from the NCGG.
Subjects who
1) are needed to restrict any physical exercise and/or diet due to functional decline, including presence of bone or joint disease, renal faiure, ischemic heart disease, and cardiopulmonary disorders.
2) are diagnosed with dementia.
3) have a MMSE score of less than 24.
4) are unable to speak in Japanese.
5) are unable to perform cognitive tests.
6) have a care-needs certification in the long-term care insurance system.
7) are deemed ineligible for enrollment by the responsible researcher or co-researcher at each institution.
500
1st name | Hidenori |
Middle name | |
Last name | Arai |
National Center for Geriatrics and Gerontology
Department of Geriatric Medicine
474-8511
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
0562-46-2311
harai@ncgg.go.jp
1st name | Hidenori |
Middle name | |
Last name | Arai |
National Center for Geriatrics and Gerontology
Department of Geriatric Medicine
474-8511
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
0562-46-2311
jmint@ncgg.go.jp
National Center for Geriatrics and Gerontology
Japan Agency for Medical Research and Development (AMED)
Japanese Governmental office
National Center for Geriatrics and Gerontology and 4 institusions in Japan
Research and Medical Division
7-430 Morioka-cho Obu Aichi Japan
0562-46-2311
yaday@ncgg.go.jp
NO
2019 | Year | 11 | Month | 25 | Day |
Unpublished
531
No longer recruiting
2019 | Year | 11 | Month | 13 | Day |
2019 | Year | 11 | Month | 13 | Day |
2019 | Year | 11 | Month | 25 | Day |
2022 | Year | 11 | Month | 30 | Day |
2019 | Year | 11 | Month | 24 | Day |
2021 | Year | 11 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044075