Multi-modal intervention for preventing dementia in older adults in Taiwan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project involves a 3-arm randomized controlled trial aimed at preventing dementia in elderly individuals in Taiwan who are at high risk but not yet diagnosed. Participants will be randomly assigned to one of three groups: an on-site intervention group, a remote intervention group utilizing digital technology, and a control group. The intervention will include management of nutrition, exercise, and cognitive programs over a two-year period, with regular monitoring of cardiovascular risk factors, physical performance, and cognitive function. The study aims to establish the Taiwan FINGER model (TaiPEI) and provide insights for future dementia prevention strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. People over 60 without dementia
2. Agree to join the study and sign the consent form
3. The Modified Rankin Scale (MRS) scores between 0-1 points
4. Education level: elementary or higher education (6 years) or can read and write Chinese
5. Very early dementia screening scale (AD-8) \< 2, or more than 2 points but without dementia diagnoses after refer to a neurologist.
6. Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score: above 8; diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD) in the past six months.

Exclusion Criteria:

1. Have been diagnosed with any kind of dementia
2. Suspected dementia patients or others who are not suitable to participate in the research assessed by a doctor at the first visit
3. Diseases affecting the safety of various interventional activities (such as remaining life less than two years, symptomatic heart/cerebrovascular disease within 6 months, vascular reperfusion or reconstruction-related surgery within one year, etc., malignant tumor within one year)
4. Severe blindness, hearing or communication impairment, or other difficulty in cooperating or completing assessments and interventions (especially exercise) in the study
5. Severe mental illnesses, including major depression disorder, or major neuromusculoskeletal disorders that are not suitable to join the study.
6. Drug or alcohol abuse in the last year
7. Overlapping with other interventional trials at the same time which may affect the evaluation results.

Where it's running

• Taipei Medical University-Shuang Ho Hospital
  New Taipei City, Taiwan Recruiting

Study contacts

• Principal investigator: Yi-Chun Kuan, MD — Taipei Medical University Shuang Ho Hospital
• Study coordinator: Yi-Chun Kuan, MD
• Email: yckuang2@gmail.com
• Phone: +886-222490088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.