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

NCT06264557 | Completed DMC

• 2 other identifiers: RW-MCI-01ROWAN
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Mild Cognitive Impairment; MCI

Keywords

SUPERBRAIN; SUPERBRAIN DEX; DEX; MCI; Digital Therapeutics

Outcome Measures

Primary Outcomes (1)

• K-RBANS

  The closer the total score of 160 points, the worse the cognitive state is, and the closer it is to 40, the worse the cognitive state is

  Baseline, 16 weeks after treatment

Secondary Outcomes (8)

• K-RBANS

  Baseline, 8 weeks after treatment

• K-MMSE-2

  Baseline, 8 weeks after treatment, and 16 weeks after treatment

• CDR-SB

  Baseline, 8 weeks after treatment, and 16 weeks after treatment

• K-IADL

  Baseline, 8 weeks after treatment, and 16 weeks after treatment

• PRMQ

  Baseline, 8 weeks after treatment, and 16 weeks after treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

Device : SB-100 Cognitive training will be conducted once a day, and it will take 15 to 30 minutes. It consists of cognitive training and educational videos.

Device: SB-100

Contol group

OTHER

Educational book : book of education on daily rules for preventing dementia

Other: Educational book

Interventions

SB-100 DEVICE

Cognitive training will be conducted once a day, and it will take 15 to 30 minutes. It consists of cognitive training and educational videos.

Treatment group

Educational book OTHER

Book of education on daily rules for preventing dementia

Contol group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years 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
• Concern of the subject or guardian about the deterioration of cognitive function compared to before
• More than one cognitive impairment
• Maintaining the independence of overall daily life functions
• It's not dementia
• 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.
• Seoul Neuropsychological Screening Battery 2nd edition (SNSB-II)
• Korean version of Consortium to Establish a Registry for Alzheimer's Disease (CERAD-K)
• Literacy Independent Cognitive Assessment (LICA)
• 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
• Defined to be able to support subjects during the clinical trial (compliance supervision and subject status reporting) and spend at least 8 hours per week with subjects
• 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

You may not qualify if:

• 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 diagnosed with infectious or metabolic diseases that may cause cognitive decline in the subject (e.g., hypothyroidism, vitamin B12 deficiency, folate deficiency, neurotoxin, HIV)
• Those with liver dysfunction (AST, ALT ≥ 3x upper limit of normal range) and/or renal dysfunction (serum creatinine ≥ 2x upper limit of normal range)
• Those with uncontrolled hypertension (SBP \> 180 mmHg) and/or diabetes (HbA1c \> 11%)
• 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)
• Where the tester determines that a person does not have sufficient vision, hearing, language skills, motor skills, and comprehension to follow the examination procedures related to clinical trials
• a person who is pregnant or nursing
• For women of childbearing age, who do not agree with the medically permitted contraceptive method during the clinical trial
• Hormonal contraception, intrauterine device (IUD) or intrauterine system (IUS), oviduct ligation, double blocking (male condom, female condom, cervical cap, a combination of contraceptive septum, contraceptive sponge-like blocking methods), a single blocking method with a combination of an alveolar agent

Sponsors & Collaborators

• Rowan: lead

Study Sites (12)

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Chonnam National University Hospital

Kwangju, South Korea

Location

Ewha Womans University Seoul Hospital

Seoul, South Korea

Location

Hanyang University Seoul Hospital

Seoul, South Korea

Location

Koera University Guro Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 20, 2024
• Study Start: January 15, 2024
• Primary Completion: March 13, 2025
• Study Completion: June 2, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (12)