UMIN-CTR Clinical Trial

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

Older adults with lifestyle-related disease.

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

Email

odawara@yokohama-cu.ac.jp

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

Email

odawara@yokohama-cu.ac.jp

Institute

Yokohama City University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

National Center for Geriatrics and Gerontology

Name of secondary funder(s)

Organization

Ethical Review Board

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa-ken, 236-0004, Japan

Tel

045-370-7627

Email

rinri@yokohama-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

09

Month

28

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/40397393/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/40397393/

Number of participants that the trial has enrolled

198

Results

198 were randomized, and 175 completed the 18-month assessment. There was no significant difference between the intervention and control groups in the primary outcome (change in composite test score: 0.25; 95% CI 0.16 to 0.33 versus 0.29; 95% CI 0.20 to 0.38, respectively;p=0.463). However, a subgroup analysis of participants with mild cognitive impairment showed a significant intervention effect on changes in logical memory, for both immediate (p=0.041) and delayed recall tasks (p=0.043).

Results date posted

2026

Year

03

Month

30

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The intervention and control groups were similar at baseline. The mean age of the intervention group was 76.3 (SD 4.4) years and that of the control group was 76.5 (SD 4.9)years. The mean number of years
of education was 13.8(SD 2.5) years and 13.9 (2.3) years, and the mean MMSE score was 28.6 (SD 1.6) and 28.6 (SD 1.4) in the interventionand control groups, respectively. As the presence of
lifestyle-related disease was one of the inclusion criteria,all participants had lifestyle-related diseases or abnormaltest values.

Participant flow

The J-MINT PRIME Kanagawa trial was an 18-month, community-based, open-label RCT of a multimodal intervention aimed at preventing the progression of dementia in older people with lifestyle-related diseases. Patients were assigned in a 1:1 ratio to either an intervention group or a control group. The intervention group received an intervention that addressed four domains: lifestyle-related disease management,physical exercise, nutritional counselling, and cognitive training. The control group received pamphlets on dementia prevention and a health education lecture once every 6 months to provide basic knowledge about dementia and lifestyle-related diseases. The participants in both groupswere evaluated at baseline and at 6, 12, and 18 months.

Adverse events

Regarding dementia onset, two participants in the intervention group were diagnosed with dementia (probable AD dementia) and none in the control group; however, the between-group difference
was not significant (p=0.238). No serious intervention-related AEs were reported.

Outcome measures

Primary outcome measure. The primary outcome was the change from baseline at 18 months in the global composite score on seven neuropsychological tests that measured the following functions: global
cognitive function [MMSE]; memory (Logical memory I and II subset of the Wechsler Memory Scale-Revised [WMS-R] and the Free and Cued Selective Reminding Test [FCSRT]); attention (Digit Span of the
Wechsler Adult Intelligence Scale [WAIS]-III); and executive function/processing speed (Trail Making Test [TMT], Digit Symbol Substitution Test [DSST] subset of the WAIS-III, and Letter word fluency
test). The composite score was generated by averaging the Z scores of the full analysis set (FAS) population for each neuropsychological test, standardized by the baseline mean and standard deviation
(SD) for each test.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

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 related information

Registered date

2020

Year

09

Month

24

Day

Last modified on

2026

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047808