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NCT Number: NCT06783465

AI-Driven Cognitive Digital Therapeutics 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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Wan Fang Hospital

Taipei City, Taipei, 116, Taiwan

Location status: Recruiting

Location contact

Jowy Tani, MD, PhD

CONTACT

[email protected]

+886965562798

Jowy Tani, MD, PhD

PRINCIPAL_INVESTIGATOR

Tian-Shin Yeh, MD, PhD

CONTACT

[email protected]

+886978730373

Tian-Shin Yeh, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital therapeutics session

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline, Week 8, Week 16

    Range: 0 to 30; Higher scores indicate better cognitive function.

  2. Mini-Mental State Examination score (MMSE)

    Time frame: Baseline, Week 8, Week 16

    Range: 0 to 30; Higher scores indicate better cognitive function.

  3. Clinical Dementia Rating score (CDR)

    Time frame: Baseline, Week 8, Week 16

    Range: 0 to 3; Higher scores indicate greater severity of dementia.

  4. Executive Function Performance Test score (EFPT)

    Time frame: Baseline, Week 8, Week 16

    Range: 0 to 100; Higher scores indicate worse executive functioning.

Other outcomes

  1. Geriatric Depression Scale (GDS-15)

    Time frame: Baseline, Week 8, Week 16

    Range: 0 to 15; Higher scores indicate greater levels of depressive symptoms.

  2. The Family Confusion Assessment Method (FAM-CAM)

    Time frame: Baseline, Week 8, Week 16

    Range: Scored as present or absent; Presence indicates delirium.

  3. Activities of Daily Living (ADL) score

    Time frame: 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.

  4. WAIS-III Digit span forward, backward, and sequencing

    Time frame: 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.

  5. Frontal assessment battery (FAB) subtest 5

    Time frame: Baseline, Week 8, Week 16

    Range: 0 to 3. Interpretation: Higher scores indicate better motor programming and cognitive flexibility, reflecting improved frontal lobe function.

  6. Zarit Burden Interview (ZBI)

    Time frame: Baseline, Week 8, Week 16

    Range: 0 to 88 (for the full scale) Interpretation: Higher scores indicate greater caregiver burden.

  7. Neuropsychiatric Inventory (NPI)

    Time frame: Baseline, Week 8, Week 16

    Range: 0 to 144; Higher scores indicate more severe neuropsychiatric symptoms across assessed domains

  8. Quality of Life Outcome for Patients with Neurologic Conditions (PROMIS)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jowy Tani, MD, PhD

CONTACT

[email protected]

+886965562798

Tian-Shin Yeh, MD, MMSc, PhD

CONTACT

[email protected]

+886978730373

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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