UMIN-CTR Clinical Trial

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
Email	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
Email	tamba.prime@gmail.com

Sponsor
Institute	Kobe University Graduate School of Health Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047783