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Mild Cognitive ImpairmentSB-DEXNCT06264557

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

A study testing SB-100 and Educational book in people with Mild Cognitive Impairment and MCI, run by Rowan at 12 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Mild Cognitive Impairment, MCI
What is being tested?
SB-100 and Educational book
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
12 sitesSouth Korea
Study dates
15 Jan 2024to 2 Jun 2025
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
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  • 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
  • Those who have no difficulty using tablet PCs
  • A person who voluntarily decides to participate in this clinical trial and agrees to the subject's explanation and consent in writing
  • Those who are willing to comply with the clinical trial plan

Who cannot join

  • 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)
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  • 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
  • Those who are currently participating in other clinical trials or who have participated in other clinical trials within 90 days of screening
  • Other, ethical or clinical trial outcomes may be impacted and deemed inappropriate by the tester

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Inje University Haeundae Paik Hospital

    Busan

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 11923

  • Inha University Hospital

    Incheon, 22332

  • Gachon University Gil Medical Center

    Incheon

  • Chonnam National University Hospital

    Kwangju

  • Ewha Womans University Seoul Hospital

    Seoul

  • Hanyang University Seoul Hospital

    Seoul

  • Koera University Guro Hospital

    Seoul

  • Korea University Anam Hospital

    Seoul

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

    Seoul

  • Ajou University Hospital

    Suwon

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

    Suwon

Other trials in South Korea

About this study

Official title: A Multicenter, Prospective, Comparative, Randomized, Independent Rater-blind, Superiority Clinical Trial to Compare the Safety and Efficacy of the Cognitive Therapy Software 'SUPERBRAIN DEX' With a Control Group for Patients With MCI

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

Read the detailed description

A multicenter, prospective, comparative, randomized, independent rater-blind, superiority, pivotal clinical trial to compare the safety and efficacy of the Cognitive therapy software 'SUPERBRAIN DEX' for improving cognitive function with a control group for patients with mild cognitive impairment

Being tested
SB-100, Educational book
Keywords
SUPERBRAIN, SUPERBRAIN DEX, DEX, MCI, Digital Therapeutics
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB-100Device

    Cognitive training will be conducted once a day, and it will take 15 to 30 minutes.

    It consists of cognitive training and educational videos.

  • Educational bookOther

    Book of education on daily rules for preventing dementia

Study groups in NCT06264557
Study groupRoleWhat they receive
Treatment groupExperimentalDevice : 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.
Receives: Device: SB-100
Contol groupOtherEducational book : book of education on daily rules for preventing dementia
Receives: Other: Educational book

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 16 weeks after treatment

Secondary outcomes (8)

  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

    Measured: Baseline, 8 weeks after treatment

  2. K-MMSE-2

    Total scores range from 0 to 30, with lower scores indicating more worsening.

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

  3. CDR-SB

    The closer to CDR 0 grade, the more normal the cognitive state, and the closer to CDR 3 grade, the worse the cognitive state.

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

  4. K-IADL

    It consists of a total of 11 items (0-3 points), and the score is calculated by dividing the total score by the number of corresponding items, and the closer it is to 3, the worse the cognitive state is.

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

  5. PRMQ

    The closer to the lowest 16 points, the normal memory ability, and the closer to the total score of 80 points, the worse the memory ability.

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

  6. GDS-15

    The closer it is to 0, the less depressed it is, and the closer it is to the total score of 15, the more depressed it is.

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

  7. QOL-AD

    The closer the total score of 52 points, the higher the quality of life, and the closer the minimum score of 13 points, the lower the quality of life.

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

  8. ADAS-Cog14

    Total scores range from 0 to 90, with higher scores indicating more worsening.

    Measured: Baseline, 16 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start15 Jan 2024
  3. Primary completion13 Mar 2025
  4. Study completion2 Jun 2025

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06264557
Sponsor's protocol ID
RW-MCI-01
Other IDs
ROWAN
Acronym
SB-DEX
Status last verified
Oct 2025
First submitted
8 Feb 2024
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SB-100 and Educational book in people with Mild Cognitive Impairment and MCI, run by Rowan at 12 sites in South Korea.

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 18 inclusion and 17 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: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

K-RBANS (time frame: Baseline, 16 weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06264557.

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 2 Oct 2025.

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