Preliminary Research Using Artificial Intelligence Techno... | NCT06513403

Studies
Preliminary Research Using Artificial Intelligence Technology to Identify Differences in Facial Expressions Between Healthy People, Patients With Cognitive Decline, and Patients With Dementia

NCT06513403

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Apr 15, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Artificial Intelligence Technology
Cognitive Decline
Dementia
Identify
Facial Expressions

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Oct 31, 2025Estimated

First Submitted Date

Jul 17, 2024

First Submission Date that Met QC Criteria

Jul 17, 2024

First Posted Date

Jul 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2025

Last Update Posted Date

Apr 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Through artificial intelligence technology, we have conducted a preliminary study aimed at identifying differences in facial expressions among healthy individuals, patients with cognitive decline, and dementia patients. This research offers a novel method and tool for dementia screening, contributing to effective strategies for dementia prevention in our country. By utilizing this approach, we can effectively delay the onset of disability, promote healthy aging among our elderly population, reduce the caregiving burden on individuals, families, and society, and lower medical expenses.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Facial Expression Test	(A) Participants will sit in front of a computer screen and watch videos depicting positive (happy) or negative (sad) emotional stimuli. Each video will be less than 60 seconds long. (B) Participants will undergo the memory recall and calculation ability tests included in the MMSE. (C) While participants are undergoing the tests, video recording equipment will be used to observe and record the facial expression responses of the three groups.	2024/8/1-2025/10/31

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 50 and 75 years.

Experimental group:
MCI group: CDR score of 0.5 or MMSE score between 20-25 (mild/early stage).
Dementia group: CDR score greater than 1 or MMSE score between 10-19 (moderate/middle stage).
Control group:
Health group: MMSE score of 26 or above.
Participants must be conscious and able to follow instructions.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Normal cognition group (Health): 20 participants
Mild cognitive impairment group (MCI): 20 participants
Dementia group: 20 participants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yang Jung-Cheng	Contact	035326151		G68010@hch.gov.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NTUH	Recruiting	Hsinchu		300	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The outcome of the current experiment is uncertain, so no decision has been made.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009633	Nonverbal Communication
D003142	Communication
D001519	Behavior

ID	Term
D060825	Cognitive Dysfunction
D003704	Dementia
D005149	Facial Expression