Clinical trial NCT06783465: AI-Driven Cognitive Digital Therapeutics for Dementia Management
Official title: AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: Baseline, Week 8, Week 16
Secondary outcomes:
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, Week 8, Week 16
measure: Mini-Mental State Examination score (MMSE)
timeFrame: Baseline, Week 8, Week 16
measure: Clinical Dementia Rating score (CDR)
timeFrame: Baseline, Week 8, Week 16
measure: Executive Function Performance Test score (EFPT)
timeFrame: Baseline, Week 8, Week 16
Other outcomes:
measure: Geriatric Depression Scale (GDS-15)
timeFrame: Baseline, Week 8, Week 16
measure: The Family Confusion Assessment Method (FAM-CAM)
timeFrame: Baseline, Week 8, Week 16
measure: Activities of Daily Living (ADL) score
timeFrame: Baseline, Week 8, Week 16
measure: WAIS-III Digit span forward, backward, and sequencing
timeFrame: Baseline, Week 8, Week 16
measure: Frontal assessment battery (FAB) subtest 5
timeFrame: Baseline, Week 8, Week 16
measure: Zarit Burden Interview (ZBI)
timeFrame: Baseline, Week 8, Week 16
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Baseline, Week 8, Week 16
measure: Quality of Life Outcome for Patients with Neurologic Conditions (PROMIS)
timeFrame: Baseline, Week 8, Week 16
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Medical University Wan Fang Hospital
state: Taipei
Study officials:
References: