Clinical trial NCT05407857: Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention
Official title: Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention (TaiPEI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 380
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups (on site intervention group, remote intervention group, and control group)
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: Change in cognition including individual cognitive domains, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Secondary outcomes:
measure: Change in physical assessment, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in physical assessment, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in physical assessment, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in physical functioning - Hand-grip strength, kg
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change of the questionnaire regarding the nutrition, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change of the questionnaire regarding the nutrition, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change of nutrition intake, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in functioning level, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in functioning level, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in functioning level, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in functioning level, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in functioning level, unit on a scale
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in depressive symptoms, unit on a scale.
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in sleep symptoms, unit on a scale.
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in sleep symptoms, unit on a scale.
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in blood tests - fasting plasma glucose, mmol/L.
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in blood tests - triglycerides, mmol/L.
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change in blood tests - Albumin, prealbumin, g/dL.
timeFrame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
measure: Change of Plasma amyloid beta, pg/mL
timeFrame: Before intervention (Baseline); During intervention (6th month and 24th month)
measure: Change of Plasma tau, pg/mL
timeFrame: Before intervention (Baseline); During intervention (6th month and 24th month)
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Yi-Chun Kuan, MD
role: PRINCIPAL_INVESTIGATOR
References: