Cognitive Impairment
Conditions
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.
Interventions
DEVICEDigital therapeutics session
During 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.
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Instrumental Activities of Daily Living (IADL) | Baseline, Week 8, Week 16 | e.g., K-IADL (Korean Instrumental Activities of Daily Living): range from 0 to 33; Higher scores = worse outcomes, lower scores = better independence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Montreal Cognitive Assessment (MoCA) | Baseline, Week 8, Week 16 | Range: 0 to 30; Higher scores indicate better cognitive function. |
| Mini-Mental State Examination score (MMSE) | Baseline, Week 8, Week 16 | Range: 0 to 30; Higher scores indicate better cognitive function. |
| Clinical Dementia Rating score (CDR) | Baseline, Week 8, Week 16 | Range: 0 to 3; Higher scores indicate greater severity of dementia. |
| Executive Function Performance Test score (EFPT) | Baseline, Week 8, Week 16 | Range: 0 to 100; Higher scores indicate worse executive functioning. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview (ZBI) | Baseline, Week 8, Week 16 | Range: 0 to 88 (for the full scale) Interpretation: Higher scores indicate greater caregiver burden. |
| Geriatric Depression Scale (GDS-15) | Baseline, Week 8, Week 16 | Range: 0 to 15; Higher scores indicate greater levels of depressive symptoms. |
| Quality of Life Outcome for Patients with Neurologic Conditions (PROMIS) | Baseline, Week 8, Week 16 | Range: Standardized T-score, typically 20 to 80; Higher scores can indicate better or worse outcomes depending on the specific domain |
| Neuropsychiatric Inventory (NPI) | Baseline, Week 8, Week 16 | Range: 0 to 144; Higher scores indicate more severe neuropsychiatric symptoms across assessed domains |
| The Family Confusion Assessment Method (FAM-CAM) | Baseline, Week 8, Week 16 | Range: Scored as present or absent; Presence indicates delirium. |
| Activities of Daily Living (ADL) score | Baseline, Week 8, Week 16 | Higher scores indicate greater independence: e.g., Katz ADL--range from 0 to 6; Barthel Index--range from 0 to 100. |
| WAIS-III Digit span forward, backward, and sequencing | Baseline, Week 8, Week 16 | 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. |
| Frontal assessment battery (FAB) subtest 5 | Baseline, Week 8, Week 16 | Range: 0 to 3. Interpretation: Higher scores indicate better motor programming and cognitive flexibility, reflecting improved frontal lobe function. |
Countries
Taiwan
Contacts
Primary ContactTian-Shin Yeh, MD, MMSc, PhD
Backup ContactJowy Tani, MD, PhD
Outcome results
None listed