Cognitive ImpairmentNCT06783465
AI-Driven Cognitive Digital Therapeutics for Dementia Management
A study testing Digital therapeutics session in people with Cognitive Impairment, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Digital therapeutics session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Wan Fang Hospital
Taipei City, Taipei, 116
Tian-Shin Yeh, MD, PhD, +886978730373, tianshin.yeh@gmail.com
Jowy Tani, MD, PhD, +886965562798, jowytani@tmu.edu.tw
About this study
Official title: AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management
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.
- Conditions
- Cognitive Impairment
- Being tested
- Digital therapeutics session
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital therapeutics sessionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Digital therapeutics session three times per week Receives: Device: Digital therapeutics session |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8, Week 16
Secondary outcomes (4)
The Montreal Cognitive Assessment (MoCA)
Range: 0 to 30; Higher scores indicate better cognitive function.
Measured: Baseline, Week 8, Week 16
Mini-Mental State Examination score (MMSE)
Range: 0 to 30; Higher scores indicate better cognitive function.
Measured: Baseline, Week 8, Week 16
Clinical Dementia Rating score (CDR)
Range: 0 to 3; Higher scores indicate greater severity of dementia.
Measured: Baseline, Week 8, Week 16
Executive Function Performance Test score (EFPT)
Range: 0 to 100; Higher scores indicate worse executive functioning.
Measured: Baseline, Week 8, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Feb 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783465
- Sponsor's protocol ID
- N202404013
- Status last verified
- Aug 2024
- First submitted
- 15 Sep 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management
- ClinicalTrials.gov ID
- NCT06783465
- Acronym / sponsor ID
- N202404013
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Digital therapeutics sessionDigital therapeutics session three times per week |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital therapeutics sessionDuring 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. | Device | Intervention |
Primary outcome
Instrumental Activities of Daily Living (IADL)
Time frame: 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.
4 secondary outcomes
The Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, Week 8, Week 16
Mini-Mental State Examination score (MMSE)
Time frame: Baseline, Week 8, Week 16
Clinical Dementia Rating score (CDR)
Time frame: Baseline, Week 8, Week 16
Executive Function Performance Test score (EFPT)
Time frame: Baseline, Week 8, Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital therapeutics session in people with Cognitive Impairment, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tian-Shin Yeh, MD, MMSc, PhD (+886978730373, tianshin.yeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instrumental Activities of Daily Living (IADL) (time frame: Baseline, Week 8, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 1 Nov 2026.