AI-Driven Cognitive Digital Therapeutics for Dementia Management

Taipei Medical University

Status

Enrolling

Conditions

Cognitive Impairment

Treatments

Device: Digital therapeutics session

Study type

Interventional

Funder types

Other

Identifiers

NCT06783465

N202404013

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.