AI-Driven Cognitive Digital Therapeutics for Dementia Management
NCT ID: NCT06783465
Last Updated: 2025-02-19
Study Results
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-02-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
Digital therapeutics session three times per week
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.
Control
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.
Eligibility Criteria
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Inclusion Criteria
2. Clinical Dementia Rating from 0.5-1
3. Physician diagnosed mild neurocognitive disorder or dementia (according to ICD-11 diagnostic criteria)
Exclusion Criteria
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.
50 Years
ALL
No
Sponsors
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Taipei Medical University WanFang Hospital
OTHER
Responsible Party
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Locations
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Taipei Medical University Wan Fang Hospital
Taipei City, Taipei, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N202404013
Identifier Type: -
Identifier Source: org_study_id
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