AI-driven digital therapy for managing dementia
AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management
This study is testing if a new digital therapy can help people with mild dementia improve their thinking skills better than just regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Taipei Medical University WanFang Hospital Academic / other |
| Locations | 1 site (Taipei City, Taipei) |
| Trial ID | NCT06783465 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a cognitive digital therapeutics system designed for individuals with mild neurocognitive disorders or dementia. Participants in the intervention group will engage in three digital therapeutic sessions per week over an 8-week period, while the control group will receive standard care. Evaluations will be conducted at baseline, after 8 weeks, and again at 16 weeks to assess cognitive improvements. The goal is to determine if digital therapeutics can enhance cognitive function in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with a clinical dementia rating of 0.5-1 and a physician-diagnosed mild neurocognitive disorder or dementia.
Not a fit: Patients with severe cognitive impairment (MMSE score below 18) or those receiving certain Alzheimer's treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-pharmacological treatment option for patients with cognitive impairment.
How similar studies have performed: While the use of digital therapeutics in cognitive impairment is an emerging field, similar studies have shown promise in improving cognitive outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taipei City, Taipei
- Taipei Medical University Wan Fang Hospital — Taipei City, Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Tian-Shin Yeh, MD, MMSc, PhD
- Email: tianshin.yeh@gmail.com
- Phone: +886978730373
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.