認知症のリスクをもつ高齢者に対する進展予防を目指した多因子介入によるランダム化比較研究

Study information

Title

Japan-multimodal intervention trial for prevention of dementia(J-MINT)

Objective

The aims of this study are:
1) to identify whether a multidomain intervention including management of lifestyle-related disease, exercise, nutritional guidance, and cognitive training can prevent the progression of cognitive decline;
2) to clarify the mechanisms of cognitive risk reduction by using blood biomarkers, omics analysis, and brain imaging analysis;
3) to conduct research in collaboration with private companies, aiming at the future social implementation of new dementia prevention services.

Study design

Open-label multicenter randomized controlled trial

Subject

Subjects who aged 65-85 and have age- and education-adjusted cognitive decline determined by using the National Center for Geriatrics and Gerontology Functional Assessment Tool (NCGG-FAT).

Period of intervention

18 months

Assessment

Primary outcome

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

Key secondary outcomes

・Changes in a composite score of cognitive tests from baseline to 6/12-month follow-up.
・Changes in scores of each cognitive test from baseline to 6/12/18-month follow-up.
・Changes in laboratory and urinary markers from baseline to 6/18-month follow-up.
・Changes in ADL scores from baseline to 6/18-month follow-up.
・Changes in the status of frailty from baseline to 6/18-month follow-up.
・Changes in brain images assessed using MRI or CT from baseline to 18-month follow-up.
・Changes in the number of medications.
・Incident dementia

Target number of subjects

500 (250 in the intervention group and 250 in the control group)

Founding source

Japan Agency for Medical Research and Development (AMED)

UMIN Clinical Trials Registry

UMIN ID:UMIN000038671
UMIN Clinical Trials Registry

Research organization

研究組織

Principal investigator

National center for Geriatrics and Gerontology, Hidenori Arai

Sub-cohort leader

Nagoya University, Masafumi Kuzuya
Nagoya City University, Makoto Michikawa
Fujita Health University, Hajime Takechi
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Yoshinori Fujiwara