UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041887 |
|---|---|
| Receipt number | R000047808 |
| Scientific Title | Japan-multimodal intervention Trial for prevention of dementia (J-MINT) in Kanagawa |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2022/09/26 11:06:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Japan-multimodal intervention Trial for prevention of dementia (J-MINT) in Kanagawa
Acronym
J-MINT PRIME Kanagawa study
Scientific Title
Japan-multimodal intervention Trial for prevention of dementia (J-MINT) in Kanagawa
Scientific Title:Acronym
J-MINT PRIME Kanagawa study
Region
| Japan |
Condition
Condition
Older adults with lifestyle-related disease.
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify whether a multidomain intervention including, 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
Exploratory
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 function 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 ADL scores from baseline to a 6/18-month follow up.
4)Changes in the status of frailty from baseline to a 6/18-month follow up.
5)Changes in the number of medications.
6)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 management 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-mintes multicomponent exercise program, including stretch, muscle strength training, aerobic exercise, exercise with dual task, and behavior modification ,will be provided once two weeks during a 18-month intervention period. A nutritional counseling using 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)live in Yokohama Wakabadai housing complex.
2)aged 65-85 at the time of enroll.
3)are treating lifestyle-related disease or with the risk of lifestyle-related disease.
4)have provided a written informed consent on this study by subjects.
Key exclusion criteria
Subjects who
1)have severe functional impairement.
2)are diagnosed with dementia.
3)have 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 renponsible researcher or co-researcher.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Odawara |
| Middle name | |
| Last name | Toshinari |
Organization
Yokoahama City University
Division name
Health Management Center
Zip code
236-0027
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa-ken,236-0027, Japan
TEL
045-787-2144
odawara@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Toshinari |
| Middle name | |
| Last name | Odawara |
Organization
Yokohama City University
Division name
Health Management Center
Zip code
236-0027
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa-ken, 236-0027, Japan
TEL
045-787-2144
Homepage URL
odawara@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa-ken, 236-0004, Japan
Tel
045-370-7627
rinri@yokohama-cu.ac.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
| 2020 | Year | 09 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047808
