UMIN-CTR Clinical Trial
| 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 | 2025/12/01 16:19:49 |
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Basic information
Public title
Japan-multimodal intervention Trial for prevention of dementia (J-MINT)
Acronym
J-MINT study
Scientific Title
Japan-multimodal intervention Trial for prevention of dementia (J-MINT)
Scientific Title:Acronym
J-MINT study
Region
| Japan |
Condition
Condition
Older adults with cognitive impairment.
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in a composite score of cognitive function from baseline to a 18-month follow-up.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
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.
Interventions/Control_2
Usual care.
Providing documents regarding lifestyle and behaviors for the prevention of dementia.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Arai |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Geriatric Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
harai@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Arai |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Geriatric Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
jmint@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology and 4 institusions in Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research and Medical Division
Address
7-430 Morioka-cho Obu Aichi Japan
Tel
0562-46-2311
yaday@ncgg.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2274580724005454?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13838
Number of participants that the trial has enrolled
531
Results
We evaluated whether a multidomain intervention prevents cognitive decline in Japanese older adults with MCI. Adults aged 65-85 were randomized to intervention or control groups. The between-group difference in cognitive composite score change was 0.047 (95% CI: -0.029 to 0.124). Secondary analyses suggested benefits in some outcomes, especially among those with high exercise attendance, APOE e4 carriers, and individuals with elevated plasma GFAP.
Results date posted
| 2025 | Year | 12 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The J-MINT recruited participants aged 65-85 years who had age- and education-adjusted cognitive decline with a standard deviation (SD) of 1.0 or more from the reference threshold for one or more of the four cognitive domains, namely, memory, attention, executive function, and processing speed, from hospitals, memory clinics, and/or community-based cohorts. Participants who needed to preclude and/or restrict physical exercise were excluded.
Participant flow
Between November 26, 2019 and December 28, 2020, 1677 participants were screened, among whom 531 were randomly assigned to the multidomain intervention (n = 265) or control group. Eventually, 406 (76%) participants completed the neuropsychological tests at the 18-month follow-up. Dropout rates were similar between the intervention (59 participants, 22%) and control (66 participants, 25%) groups (p = 0.147). The full analysis set included 433 participants (82% of all randomized participants) after excluding 81 participants who withdrew immediately after randomization and 17 participants without any postbaseline assessment of neuropsychological tests.
Adverse events
In the safety analysis set (n = 447), 83 (37%) and 65 participants (29%) in the intervention and control groups reported at least one adverse event, respectively.
Outcome measures
The primary outcome was the change from baseline in a global composite score combining several neuropsychological tests at the 18-month follow-up. Neuropsychological tests in this trial included the Mini-Mental State Examination (MMSE) for global cognitive function; the Logical Memory I and II subset of the Wechsler Memory Scale Revised (WMS-R); the Free and Cued Selective Reminding Test (FCSRT) for memory function; Digit Span of the Wechsler Adult Intelligence Scale (WAIS) III; Trail Making Test (TMT); Digit Symbol Substitution Test (DSST) subset of the WAIS III; and letter word fluency test for executive function/processing speed. The composite score was generated by averaging the Z scores for each neuropsychological test standardized by the baseline mean and SD for each test in the full-analysis set (FAS). When calculating the composite score, inverse Z scores were used for the TMT because a lower score indicates better function.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044075
