AI-Driven Cognitive Digital Therapeutics for Dementia Management

NCT06783465 | Recruiting

• 1 other identifier: N202404013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Montreal Cognitive Assessment (MoCA)

  Baseline, Week 8, Week 16

• Mini-Mental State Examination score (MMSE)

  Baseline, Week 8, Week 16

• Clinical Dementia Rating score (CDR)

  Baseline, Week 8, Week 16

• Executive Function Performance Test score (EFPT)

  Baseline, Week 8, Week 16

Other Outcomes (8)

• Geriatric Depression Scale (GDS-15)

  Baseline, Week 8, Week 16

• The Family Confusion Assessment Method (FAM-CAM)

  Baseline, Week 8, Week 16

• Activities of Daily Living (ADL) score

  Baseline, Week 8, Week 16

Study Arms (2)

Intervention

EXPERIMENTAL

Digital therapeutics session three times per week

Device: Digital therapeutics session

Control

NO INTERVENTION

Interventions

Digital therapeutics session DEVICE

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.

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Mini-mental state examination score below 18
• 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.
• Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's mild neurocognitive disorder or dementia.
• History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
• Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant.
• Geriatric Depression Scale (GDS) score greater than or equal to 10 at Screening.
• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University Wan Fang Hospital

Taipei City, Taipei, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Tian-Shin Yeh, MD, MMSc, PhD

CONTACT

+886978730373; tianshin.yeh@gmail.com

Jowy Tani, MD, PhD

CONTACT

+886965562798; jowytani@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: January 20, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2024-08

Locations

TW (1)