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.
Eligibility
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.