AI-Driven Cognitive Digital Therapeutics for Dementia Management

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorTaipei Medical University WanFang Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Digital therapeutics session

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Taipei Medical University Wan Fang HospitalRecruiting116, Taipei City, TaipeiTaiwanTaiwan