AI-Driven Cognitive Digital Therapeutics for Dementia Management
ConditionCognitive Impairment
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Digital therapeutics session
DeviceDuring the digital therapeutics session, the patient performs tasks by handling objects according to instructions displayed by the device. A camera records the task performance, and the system analyzes the task performance.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Instrumental Activities of Daily Living (IADL)
e.g., K-IADL (Korean Instrumental Activities of Daily Living): range from 0 to 33; Higher scores = worse outcomes, lower scores = better independence.
Time frame
Baseline, Week 8, Week 16Secondary outcomes
1
The Montreal Cognitive Assessment (MoCA)
Range: 0 to 30; Higher scores indicate better cognitive function.
Time frame
Baseline, Week 8, Week 162
Mini-Mental State Examination score (MMSE)
Range: 0 to 30; Higher scores indicate better cognitive function.
Time frame
Baseline, Week 8, Week 163
Clinical Dementia Rating score (CDR)
Range: 0 to 3; Higher scores indicate greater severity of dementia.
Time frame
Baseline, Week 8, Week 164
Executive Function Performance Test score (EFPT)
Range: 0 to 100; Higher scores indicate worse executive functioning.
Time frame
Baseline, Week 8, Week 16Other outcomes
1
Geriatric Depression Scale (GDS-15)
Range: 0 to 15; Higher scores indicate greater levels of depressive symptoms.
Time frame
Baseline, Week 8, Week 162
The Family Confusion Assessment Method (FAM-CAM)
Range: Scored as present or absent; Presence indicates delirium.
Time frame
Baseline, Week 8, Week 163
Activities of Daily Living (ADL) score
Higher scores indicate greater independence: e.g., Katz ADL--range from 0 to 6; Barthel Index--range from 0 to 100.
Time frame
Baseline, Week 8, Week 164
WAIS-III Digit span forward, backward, and sequencing
Range: Variable (raw scores depend on the total number of correct trials, typically ranging from 0 to \~30, depending on individual performance). Standardized Scoring: Raw scores are converted to age-specific scaled scores, typically ranging from 1 to 19. Interpretation: Higher scores indicate better short-term memory, working memory, and cognitive processing capacity.
Time frame
Baseline, Week 8, Week 16Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Taipei Medical University Wan Fang HospitalRecruiting116, Taipei City, Taipei
Taiwan
TaiwanSponsors and contacts
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Source ClinicalTrials.gov