AI-Driven Cognitive Digital Therapeutics for Dementia Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital therapeutics session.
- Who it may be relevant to
- Registry conditions: Cognitive Impairment. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management
Overview
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.
Interventions
- 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.
Primary outcome measures
- Instrumental Activities of Daily Living (IADL) [Time frame: Baseline, Week 8, Week 16]
Secondary outcome measures (4)
- The Montreal Cognitive Assessment (MoCA) [Time frame: Baseline, Week 8, Week 16]
- Mini-Mental State Examination score (MMSE) [Time frame: Baseline, Week 8, Week 16]
- Clinical Dementia Rating score (CDR) [Time frame: Baseline, Week 8, Week 16]
- Executive Function Performance Test score (EFPT) [Time frame: Baseline, Week 8, Week 16]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Medical University Wan Fang Hospital — Taipei City
Identifiers
NCT: NCT06783465 · N202404013