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

Taipei Medical University Shuang Ho Hospital380 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

380

Conditions

Dementia

Interventions

multi-modal non-pharmacological interventionBEHAVIORAL

multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Central Contacts

Yi-Chun Kuan, MD

CONTACT

+886-222490088 yckuang2@gmail.com

Data from ClinicalTrials.gov

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Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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),

Time frame: 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),

Time frame: Before intervention (Baseline); During intervention (6th month and 24th month)