- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407857
Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention (TaiPEI)
October 27, 2022 updated by: Yi-Chun Kuan, Taipei Medical University Shuang Ho Hospital
Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention (TaiPEI)
A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
380
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi-Chun Kuan, MD
- Phone Number: 8112 +886-222490088
- Email: yckuang2@gmail.com
Study Locations
-
-
-
New Taipei City, Taiwan, 235
- Recruiting
- Taipei Medical University-Shuang Ho Hospital
-
Contact:
- Yi-Chun Kuan
- Phone Number: 0970747553
- Email: yckuang2@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: On-site
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.
|
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
|
ACTIVE_COMPARATOR: Remote
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.
|
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
|
PLACEBO_COMPARATOR: Control
The control group will also receive the same health evaluation and education as all intervention groups.
|
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognition including individual cognitive domains, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
|
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
Time Frame: Before intervention (Baseline); During intervention (6th month and 24th month)
|
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
Time Frame: Before intervention (Baseline); During intervention (6th month and 24th month)
|
Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ),
|
Before intervention (Baseline); During intervention (6th month and 24th month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2022
Primary Completion (ANTICIPATED)
December 1, 2026
Study Completion (ANTICIPATED)
December 1, 2026
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (ACTUAL)
June 7, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 28, 2022
Last Update Submitted That Met QC Criteria
October 27, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202112075
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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