AI-Driven Cognitive Digital Therapeutics for Dementia Management

AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment
• Intervention / Treatment: Device: Digital therapeutics session

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tian-Shin Yeh, MD, MMSc, PhD; Phone Number: +886978730373; Email: tianshin.yeh@gmail.com
• Study Contact Backup: Name: Jowy Tani, MD, PhD; Phone Number: +886965562798; Email: jowytani@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei
    • Taipei City, Taipei, Taiwan, 116
      • Recruiting
      • Taipei Medical University Wan Fang Hospital
      • Contact: Jowy Tani, MD, PhD; Phone Number: +886965562798; Email: jowytani@tmu.edu.tw
      • Contact: Tian-Shin Yeh, MD, PhD; Phone Number: +886978730373; Email: tianshin.yeh@gmail.com
      • Principal Investigator: Tian-Shin Yeh, MD, PhD
      • Principal Investigator: Jowy Tani, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Intervention; Digital therapeutics session three times per week	Device: Digital therapeutics session; During the digital therapeutics session, the patient performs tasks by handling objects according to instructions displayed by the device. A camera records the task performance, and the system analyzes the task performance.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geriatric Depression Scale (GDS-15)	Range: 0 to 15; Higher scores indicate greater levels of depressive symptoms.	Baseline, Week 8, Week 16
The Family Confusion Assessment Method (FAM-CAM)	Range: Scored as present or absent; Presence indicates delirium.	Baseline, Week 8, Week 16
Activities of Daily Living (ADL) score	Higher scores indicate greater independence: e.g., Katz ADL--range from 0 to 6; Barthel Index--range from 0 to 100.	Baseline, Week 8, Week 16
WAIS-III Digit span forward, backward, and sequencing	Range: Variable (raw scores depend on the total number of correct trials, typically ranging from 0 to ~30, depending on individual performance). Standardized Scoring: Raw scores are converted to age-specific scaled scores, typically ranging from 1 to 19. Interpretation: Higher scores indicate better short-term memory, working memory, and cognitive processing capacity.	Baseline, Week 8, Week 16
Frontal assessment battery (FAB) subtest 5	Range: 0 to 3. Interpretation: Higher scores indicate better motor programming and cognitive flexibility, reflecting improved frontal lobe function.	Baseline, Week 8, Week 16
Zarit Burden Interview (ZBI)	Range: 0 to 88 (for the full scale) Interpretation: Higher scores indicate greater caregiver burden.	Baseline, Week 8, Week 16
Neuropsychiatric Inventory (NPI)	Range: 0 to 144; Higher scores indicate more severe neuropsychiatric symptoms across assessed domains	Baseline, Week 8, Week 16
Quality of Life Outcome for Patients with Neurologic Conditions (PROMIS)	Range: Standardized T-score, typically 20 to 80; Higher scores can indicate better or worse outcomes depending on the specific domain	Baseline, Week 8, Week 16

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: N202404013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No