CompletedNot Applicable

Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment

South Korea140 participantsStarted 2024-01-15

Plain-language summary

Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment

Who can participate

Age range50 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 50 - 85years old
✓. Those who meet all of the National Institute on Aging-Alzheimer's Association (NIA-AA) key clinical criteria below that may suspect mild cognitive impairment caused by Alzheimer's disease as of the screening date
✓. In at least one of the following neuropsychological tests conducted within one year of the screening date, the delayed recall score in the memory area was 'average -1' according to the standard score table corrected for education level and age.
✓. A person whose Korea-Mini Mental State Examination-2 (K-MMSE-2) score corresponds to "Average-1.5 standard deviation or higher" according to the standard score table corrected for education level and age as of the screening date
✓. Those with a Global Clinical Dementia Rating (CDR) score of 0.5 and a memory item score of 0.5 or 1 as of the screening date
✓. A person who has a guardian in regular contact with the subject
✓. A person who is taking drugs (donepezil, galantamine, ribastigmine, memantine) for the purpose of improving cognitive function is taking drugs stably for at least 12 weeks as of the screening date
✓. Those who have no difficulty using tablet PCs

Exclusion criteria

✕. Those diagnosed with dementia (including Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., Human Immunodeficiency Virus (HIV), syphilis, etc.), Creutzfeld-Jacob disease (Creutzfeld-Jacob disease), Pick disease, Huntington's disease, Parkinson's disease, etc.) as of the screening date
✕. Those who have a history of diagnosing significant neurological diseases affecting cognitive function within one year of the screening date (e.g., stroke, multiple sclerosis, severe head trauma with loss of consciousness, normal cerebral hydrocephalus, epilepsy, brain tumors, cerebral infarction, spinal cord infarction or central nervous system infection)
✕. Based on the screening date, major depressive disorder, bipolar disorder, schizophrenia, A person diagnosed with a serious mental illness such as drug addiction and alcoholism
✕. Laboratory and/or vital signs tests as of the date of screening, any of the following
✕. Those who have severe or unstable cardiovascular disease (e.g., myocardial infarction, unstable angina, class III or IV heart failure by classification of the New York Heart Association (NYHA) within 24 weeks of the screening date)
✕. Where the tester determines that he/she has a medical condition that may interfere with the completion of the clinical trial due to a serious or unstable physical condition (e.g., a history of malignant tumors within five years of the screening date (e.g., basal cell cancer and squamous cell carcinoma of the skin considered to have been completely resected and cured, cervical intraepithelial carcinoma, non-transparent prostate cancer, acute and severe asthma, active peptic ulcers, etc.)
✕. If you can't walk, A person who can move using walking aids (e.g. walkers, canes, wheelchairs, etc.)
✕. an illiterate patient who is unschooled (defined as unadmitted to a regular school)

What they're measuring

K-RBANS

Timeframe: Baseline, 16 weeks after treatment

Trial details

NCT IDNCT06264557

SponsorRowan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-13

View on ClinicalTrials.gov More Mild Cognitive Impairment trials