UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041938 |
|---|---|
| Receipt number | R000047783 |
| Scientific Title | Randomized controlled study with multifactorial intervention to prevent progression in elderly people at risk for dementia |
| Date of disclosure of the study information | 2020/09/29 |
| Last modified on | 2021/04/09 14:16:33 |
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Basic information
Public title
Randomized controlled study with multifactorial intervention to prevent progression in elderly people at risk for dementia
Acronym
Japan-multimodal intervention Trial for prevention of dementia (J-MINT) PRIME Tamba study
Scientific Title
Randomized controlled study with multifactorial intervention to prevent progression in elderly people at risk for dementia
Scientific Title:Acronym
Japan-multimodal intervention Trial for prevention of dementia (J-MINT) PRIME Tamba study
Region
| Japan |
Condition
Condition
Older adults with risk of cognitive impairment
Classification by specialty
| Neurology | 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 cardiovascular risk.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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 6/12/36-month follow-up.
2) Changes in scores of each cognitive test from baseline to a 6/12/18/36-month follow-up.
3) Changes in laboratory markers from baseline to a 6/18/36-month follow-up.
4) Changes in ADL scores from baseline to a 6/18/36-month follow-up.
5) Changes in the status of frailty from baseline to a 6/18/36-month follow-up.
6) Changes in each result of a comprehensive geriatric assessment from baseline to a 6/18/36-month follow-up.
7) Changes in reaction time from baseline to an 18-month follow-up.
8) Changes in Cognitive function screening from baseline to an 18-month follow-up.
9) Incident dementia.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
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 in Tamba city.
2) have DASC-21 total score is in the range of 22 -30 points.
3) have at least 1 of the following vascular risks (Treating hypertension or having systolic BP >=140 mm Hg or diastolic BP >= 85 mm Hg. Treating diabetes or HbA1c >=6.0%)
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 primary or primary care physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Rehabilitation Science
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo 654-0142, JAPAN
TEL
078-792-2555
kowa@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Center for Preventing Dementia
Zip code
654-1042
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo 654-0142, JAPAN
TEL
078-796-4514
Homepage URL
tamba.prime@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Ethics Committee for Health Sciences
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo 654-0142, JAPAN
Tel
078-796-4502
syomu2@ams.kobe-u.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 | 29 | 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
203
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 | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 10 | 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 | 29 | Day |
Last modified on
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047783
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