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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038671
Receipt No. 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 2019/11/24

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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.

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 considered as adjustment factor in dynamic allocation.
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 1.5 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 440

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
Email 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
Email jmint@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
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 03 Month 31 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
2019 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044075

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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