Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-01 @ 12:19 PM
Study NCT ID:
NCT05407857
Status:
RECRUITING
Last Update Posted:
2022-10-28
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention
Sponsor:
Taipei Medical University Shuang Ho Hospital
Organization:
Study Overview
Official Title:
Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention (TaiPEI)
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TaiPEI
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: