Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06783465

AI-Driven Cognitive Digital Therapeutics for Dementia Management

Led by Taipei Medical University WanFang Hospital · Updated on 2025-02-19

30

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study would investigate the effect of a cognitive digital therapeutics system. The intervention group would receive three digital therapeutics sessions per week for 8 weeks, while the control group would receive usual care. Evaluations would be done at baseline, week 8, and week 16.

CONDITIONS

Official Title

AI-Driven Cognitive Digital Therapeutics for Dementia Management

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 50 years old
  • Clinical Dementia Rating from 0.5 to 1
  • Physician diagnosed mild neurocognitive disorder or dementia according to ICD-11 diagnostic criteria
Not Eligible

You will not qualify if you...

  • Mini-mental state examination score below 18
  • Receiving Alzheimer's disease treatment (AChEIs or memantine) but not on a stable dose for at least 4 weeks before baseline
  • Neurological conditions causing cognitive impairment beyond mild neurocognitive disorder or dementia
  • History of transient ischemic attacks, stroke, or seizures within 12 months before screening
  • Psychiatric diagnosis or symptoms that could interfere with study procedures, such as hallucinations, major depression, or delusions
  • Geriatric Depression Scale score of 10 or higher at screening
  • Participation in a clinical study involving new chemical entities for Alzheimer's disease within 6 months before screening unless in placebo arm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Taipei Medical University Wan Fang Hospital

Taipei City, Taipei, Taiwan, 116

Actively Recruiting

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Research Team

T

Tian-Shin Yeh, MD, MMSc, PhD

CONTACT

J

Jowy Tani, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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AI-Driven Cognitive Digital Therapeutics for Dementia Management | DecenTrialz