DementiaTaiPEINCT05407857
Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention
A study testing multi-modal non-pharmacological intervention in people with Dementia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- multi-modal non-pharmacological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
Yi-Chun Kuan, 0970747553, yckuang2@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Dementia
- Being tested
- multi-modal non-pharmacological intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-modal non-pharmacological interventionBehavioural
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
| Study group | Role | What they receive |
|---|---|---|
| On-site | Experimental | 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. Receives: Behavioral: multi-modal non-pharmacological intervention |
| Remote | Active comparator | 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. Receives: Behavioral: multi-modal non-pharmacological intervention |
| Control | Placebo comparator | The control group will also receive the same health evaluation and education as all intervention groups. Receives: Behavioral: multi-modal non-pharmacological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Secondary outcomes (20)
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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),
Measured: 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),
Measured: Before intervention (Baseline); During intervention (6th month and 24th month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups (on site intervention group, remote intervention group, and control group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Chun Kuan, Taipei Medical University Shuang Ho Hospital
- Investigators
- Yi-Chun Kuan, MD, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407857
- Sponsor's protocol ID
- N202112075
- Acronym
- TaiPEI
- Status last verified
- Oct 2022
- First submitted
- 31 Jan 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention (TaiPEI)
- ClinicalTrials.gov ID
- NCT05407857
- Acronym / sponsor ID
- TaiPEI / N202112075
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups (on site intervention group, remote intervention group, and control group)
| Arm | Type | Receives |
|---|---|---|
| On-site | Experimental | Behavioral: multi-modal non-pharmacological interventionThe 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. |
| Remote | Active comparator | Behavioral: multi-modal non-pharmacological interventionThe 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. |
| Control | Placebo comparator | Behavioral: multi-modal non-pharmacological interventionThe control group will also receive the same health evaluation and education as all intervention groups. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-modal non-pharmacological interventionmulti-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs | Behavioural | Control, On-site, Remote |
Primary outcome
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.
20 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Change in blood tests - triglycerides, mmol/L.
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.
Time frame: 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)
Change of Plasma tau, pg/mL
Time frame: Before intervention (Baseline); During intervention (6th month and 24th month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi-Chun Kuan, MD principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-modal non-pharmacological intervention in people with Dementia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chun Kuan, MD (+886-222490088 ext. 8112, yckuang2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.