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Randomized controlled study with multifactorial intervention to prevent progression in elderly people at risk for dementia

Randomized controlled study with multifactorial intervention to prevent progression in elderly people at risk for dementia - Japan-multimodal intervention Trial for prevention of dementia (J-MINT) PRIME Tamba study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041938
Enrollment
200
Registered
2020-09-29
Start date
2020-09-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older adults with risk of cognitive impairment

Interventions

Multidomain intervention including the magement of lifestyle-related disease, exercise, nutritional guidance, and cognitive training. Diabetes, hypertension, and dyslipidemia will be treated accordin
will be provided by using iPad. Providing documents regarding lifestyle and behaviors for the prevention of dementia.

Sponsors

Kobe University Graduate School of Health Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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%)

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Change in a composite score of cognitive function from baseline to a 18-month follow-up

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactHisatomo Kowa

Kobe University Graduate School of Health Sciences Center for Preventing Dementia

tamba.prime@gmail.com078-796-4514

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026