AI-Driven Cognitive Digital Therapeutics for Dementia Management

NCT ID: NCT06783465

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention

Digital therapeutics session three times per week

Group Type EXPERIMENTAL

Digital therapeutics session

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Medical University Wan Fang Hospital

Taipei City, Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tian-Shin Yeh, MD, MMSc, PhD

Role: CONTACT

+886978730373

Jowy Tani, MD, PhD

Role: CONTACT

+886965562798

Facility Contacts

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Tian-Shin Yeh, MD, PhD

Role: primary

+886978730373

Jowy Tani, MD, PhD

Role: backup

+886965562798

Other Identifiers

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N202404013

Identifier Type: -

Identifier Source: org_study_id

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