Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060226) titled 'Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial' on Jan. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - National Center for Geriatrics and Gerontology

Condition: Condition - Community-dwelling adults aged 60 to 80 years without dementia who are identified as having hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) or hyperglycemia (HbA1c >=6.5%). Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - This study aims to evaluate the effectiveness of a community-based multidomain intervention program in preventing the progression of cognitive impairment over a 12-month period among community-dwelling older adults at risk for dementia. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Two sets of the 6-month community-based J-MINT program (a multidomain intervention including exercise, nutrition, cognitive training, social participation, and vascular risk management) will be provided during the intervention period. Interventions/Control_2 - Participants in the control group will receive usual care and general health information provided by the municipality. No structured multidomain intervention program will be implemented.

Eligibility: Age-lower limit - 60 years-old = Gender - Male and Female Key inclusion criteria - 1) Individuals aged 60 to 80 years at the time of enrollment 2) Individuals with vascular risk factors, defined as hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) or hyperglycemia (HbA1c >=6.5%) 3) Individuals with a total score of 22 to 30 on the Dementia Assessment Sheet in Community-based Integrated Care System - 21 items (DASC-21) 4) Individuals who receive a full explanation of the study using the written informed consent form and provide written informed consent. Key exclusion criteria - 1) Individuals with severe functional impairment requiring prohibition or restriction of physical activity or dietary/fluid intake (including musculoskeletal disorders, renal failure, ischemic heart disease, or cardiopulmonary dysfunction). 2) Individuals with systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg 3) Individuals with a diagnosed dementia 4) Individuals who are unable to communicate in Japanese 5) Individuals who are unable to undergo cognitive or physical assessments 6) Individuals who have been certified as needing long-term care at level 1 or higher under the Japanese Long-Term Care Insurance system 7) Individuals with a history of major depressive disorder, bipolar disorder, schizophrenia, alcohol dependence, drug dependence, or with unstable or severe medical conditions 8) Individuals deemed unsuitable for participation by their attending physician due to concerns such as potential worsening of underlying medical conditions Target Size - 680

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 14 Day Date of IRB - 2025 Year 08 Month 14 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068870

Disclaimer: Curated by HT Syndication.