AI-Driven Cognitive Digital Therapeutics for Dementia Management

Not Applicable

Recruiting

• Conditions: Cognitive Impairment

• Registration Number: NCT06783465
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-02-01
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age at least 50 years old.
2. Clinical Dementia Rating from 0.5-1
3. Physician diagnosed mild neurocognitive disorder or dementia (according to ICD-11 diagnostic criteria)

Exclusion Criteria

1. Mini-mental state examination score below 18
2. If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable dose for at least 4 weeks prior to Baseline.
3. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's mild neurocognitive disorder or dementia.
4. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
5. Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant.
6. Geriatric Depression Scale (GDS) score greater than or equal to 10 at Screening.
7. Participants who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to screening unless it can be documented that the participant was in a placebo treatment arm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Instrumental Activities of Daily Living (IADL)	Baseline, Week 8, Week 16	e.g., K-IADL (Korean Instrumental Activities of Daily Living): range from 0 to 33; Higher scores = worse outcomes, lower scores = better independence.

Secondary Outcome Measures

Name	Time	Method
The Montreal Cognitive Assessment (MoCA)	Baseline, Week 8, Week 16	Range: 0 to 30; Higher scores indicate better cognitive function.
Mini-Mental State Examination score (MMSE)	Baseline, Week 8, Week 16	Range: 0 to 30; Higher scores indicate better cognitive function.
Clinical Dementia Rating score (CDR)	Baseline, Week 8, Week 16	Range: 0 to 3; Higher scores indicate greater severity of dementia.
Executive Function Performance Test score (EFPT)	Baseline, Week 8, Week 16	Range: 0 to 100; Higher scores indicate worse executive functioning.

Trial Locations

Locations (1)

Taipei Medical University Wan Fang Hospital; 🇨🇳 Taipei City, Taipei, Taiwan