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

Study Overview
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Brief Summary
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A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people

Detailed Description
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This project proposes an intervention program for dementia prevention based on the Taiwanese model. The investigator(s) will screen the elderly who are not yet demented but are at high risk of dementia and will randomly allocate them into three groups (on site intervention group, remote intervention group, and control group) for a two-year multi-modal non-pharmacological intervention. All intervention groups will be actively involved in management with nutrition, exercise and cognitive programs. The on-site intervention group requires subjects to participate in prescribed place according to the protocol. The remote intervention group is designed for reducing the chances of person-to-person contact response to the current coronavirus disease 2019 (COVID-19) pandemic and development of digital internet. It uses innovative technology combining wearable devices with inertial measurement units, blue-tooth equipment, apps, feedback technology and artificial intelligence based remote comprehensive training programs. During the study period, each group will be regularly monitored the changes of cardiovascular risk factors, physical performance and cognitive function. The results of multimodal intervention mainly from Taipei and New Taipei City will establish the Taiwan FINGER model (TaiPEI) and will have the information of the conditions and feasibility achieved in Taiwan and implementation suggestions in the face of the epidemic. It can be subsequently applied to the brain/body health care institution and to the prevention of dementia and cardiovascular disease of elderly.

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

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: multi-modal non-pharmacological intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People over 60 without dementia Agree to join the study and sign the consent form The Modified Rankin Scale (MRS) scores between 0-1 points Education level: elementary or higher education (6 years) or can read and write Chinese Very early dementia screening scale (AD-8) < 2, or more than 2 points but without dementia diagnoses after refer to a neurologist. 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: Have been diagnosed with any kind of dementia Suspected dementia patients or others who are not suitable to participate in the research assessed by a doctor at the first visit 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) Severe blindness, hearing or communication impairment, or other difficulty in cooperating or completing assessments and interventions (especially exercise) in the study Severe mental illnesses, including major depression disorder, or major neuromusculoskeletal disorders that are not suitable to join the study. Drug or alcohol abuse in the last year Overlapping with other interventional trials at the same time which may affect the evaluation results.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups (on site intervention group, remote intervention group, and control group)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: On-site<br>The on-site multi-modal intervention will be actively involved in management with nutrition, exercise and cognitive programs. The on-site intervention group requires subjects to participate in prescribed place according to the protocol. | Behavioral: multi-modal non-pharmacological intervention<br>* multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs<br>|
| Active Comparator: Remote<br>The remote intervention group is designed for reducing the chances of person-to-person contact response to the current COVID-19 pandemic and development of digital internet. It uses innovative technology combining wearable devices with inertial measurement units, blue-tooth equipment, apps, feedback technology and artificial intelligence based remote comprehensive training programs. | Behavioral: multi-modal non-pharmacological intervention<br>* multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs<br>|
| Placebo Comparator: Control<br>The control group will also receive the same health evaluation and education as all intervention groups. | Behavioral: multi-modal non-pharmacological intervention<br>* multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognition including individual cognitive domains, unit on a scale | A composite z-score will be obtained from the neuropsychological tests evaluating multiple cognitive domains, including memory, language, process speed, visuospatial, and executive function. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical assessment, unit on a scale | Senior Fitness Test (SFT) measures six functional areas of physical function (strength, endurance, balance, agility, and flexibility) | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in physical assessment, unit on a scale | Short Physical Performance Battery (SPPB), score range: 0-12; higher scores mean a better outcome. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in physical assessment, unit on a scale | International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in physical functioning - Hand-grip strength, kg | Measured using a hand-grip dynamometer | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change of the questionnaire regarding the nutrition, unit on a scale | Mini Nutritional Assessment-Short Form (MNA-SF), a screening scale used to assess current nutritional status. score range: 0-14, higher scores mean a better outcome. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change of the questionnaire regarding the nutrition, unit on a scale | food frequency questionnaire (FFQ), a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change of nutrition intake, unit on a scale | 3-day dietary record: a self-reported account of all foods and beverages consumed within recent three days | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in functioning level, unit on a scale | Activities of Daily Living Questionnaire (ADLQ) | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in functioning level, unit on a scale | The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA-Brief) -Traditional Chinese Version: two subdomains (Finances, Communication) with a total score ranging from 0 to 100. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in functioning level, unit on a scale | Florida Cognitive Activities Scale (FCAS): a 25-item scale used to assess cognitive activities in the elderly with two subscales (Higher Cognitive Abilities and Frequent Cognitive Abilities) | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in functioning level, unit on a scale | EuroQol five-dimensional (EQ-5D): an instrument for measuring quality of life regarding the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in functioning level, unit on a scale | Activities of Daily Living Questionnaire (ADLQ), The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment（Traditional Chinese Version）（UPSA-Brief）, Florida Cognitive Activities Scale(FCAS), EuroQol five-dimensional (EQ-5D) | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in depressive symptoms, unit on a scale. | Geriatric Depression Scale-Short Form (GDS-S), score range: 0-15; higher scores mean a worse outcome. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in sleep symptoms, unit on a scale. | Epworth sleepiness scale (ESS) | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in sleep symptoms, unit on a scale. | Pittsburgh Sleep Quality Index (PSQI) | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in blood tests - fasting plasma glucose, mmol/L. | Measured from fasting blood sample | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in blood tests - triglycerides, mmol/L. | Measured from fasting blood sample | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change in blood tests - Albumin, prealbumin, g/dL. | Measured from fasting blood sample | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | 
| Change of Plasma amyloid beta, pg/mL | Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ), | Before intervention (Baseline); During intervention (6th month and 24th month) | 
| Change of Plasma tau, pg/mL | Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ), | Before intervention (Baseline); During intervention (6th month and 24th month) |