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

Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention (TaiPEI)

This study is testing a new program that combines nutrition, exercise, and brain activities to see if it can help prevent dementia in older adults in Taiwan who are at high risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 60 Years to 90 Years
• Sex: All
• Sponsor: Taipei Medical University Shuang Ho Hospital (Academic / other)
• Locations: 1 site (New Taipei City)
• Trial ID: NCT05407857 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals over 60 years old without dementia but at high risk, including those with mild cognitive impairment or subjective cognitive decline.

Not a fit: Patients who have already been diagnosed with any form of dementia or those with severe health conditions that could affect their safety during the intervention will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of dementia in older adults, enhancing their cognitive health and quality of life.

How similar studies have performed: Other studies have shown success with similar multi-modal non-pharmacological interventions for dementia prevention, indicating a promising approach.

Eligibility criteria

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 this trial is running

New Taipei City

• 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

Conditions Dementia