Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment (SB-DEX)

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

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; MCI
• Intervention / Treatment: Device: SB-100; Other: Educational book

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

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyunsung Yoon; Phone Number: 010-5544-0970; Email: yswon111@rowan.kr
• Study Contact Backup: Name: Yeji Hwang; Phone Number: 010-6697-2739; Email: yjss1305@rowan.kr

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Recruiting
    • Inje University Haeundae Paik Hospital
    • Contact: Jinse Park, PI
  • Incheon, Korea, Republic of, 22332
    • Recruiting
    • Inha University Hospital
    • Contact: Hyewon Yoon, PI
  • Incheon, Korea, Republic of
    • Recruiting
    • Gachon University Gil Medical Center
    • Contact: Kee Hyung Park, PI
  • Kwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Soo Hyun Cho, PI
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Chan Nyoung Leee, PI
  • Seoul, Korea, Republic of
    • Recruiting
    • Hanyang University Seoul Hospital
    • Contact: Jin Seok Park, PI
  • Seoul, Korea, Republic of
    • Recruiting
    • Koera University Guro Hospital
    • Contact: Chi Kyung Kim, PI
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Contact: Dong Woo Kang, PI
  • Seoul, Korea, Republic of
    • Recruiting
    • Ewha Womans University Seoul Hospital
    • Contact: Ji Young Yun, PI
  • Suwon, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea, St. Vincent's Hospital
    • Contact: Yoo Hyun Um, PI
  • Suwon, Korea, Republic of
    • Recruiting
    • Ajou University Hospital
    • Contact: Sun Min Lee, PI
  • Gyeonggi-do
    • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
      • Recruiting
      • Hanyang University Guri Hospital
      • Contact: Hojin Choi, PI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 50 - 85years old

2. 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

3. 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)
4. 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
5. 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

6. 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
7. 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
8. Those who have no difficulty using tablet PCs
9. A person who voluntarily decides to participate in this clinical trial and agrees to the subject's explanation and consent in writing
10. Those who are willing to comply with the clinical trial plan

Exclusion Criteria:

1. 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
2. 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)
3. 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

4. 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%)
5. 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)
6. 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.)
7. If you can't walk, A person who can move using walking aids (e.g. walkers, canes, wheelchairs, etc.)
8. an illiterate patient who is unschooled (defined as unadmitted to a regular school)
9. 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
10. a person who is pregnant or nursing

11. 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
12. Those who are currently participating in other clinical trials or who have participated in other clinical trials within 90 days of screening
13. Other, ethical or clinical trial outcomes may be impacted and deemed inappropriate by the tester

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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; Cognitive training will be conducted once a day, and it will take 15 to 30 minutes. It consists of cognitive training and educational videos.
Other: Contol group; Educational book : book of education on daily rules for preventing dementia	Other: Educational book; Book of education on daily rules for preventing dementia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 8 weeks after treatment
K-MMSE-2	Total scores range from 0 to 30, with lower scores indicating more worsening.	Baseline, 8 weeks after treatment, and 16 weeks after treatment
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.	Baseline, 8 weeks after treatment, and 16 weeks after treatment
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.	Baseline, 8 weeks after treatment, and 16 weeks after treatment
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.	Baseline, 8 weeks after treatment, and 16 weeks after treatment
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.	Baseline, 8 weeks after treatment, and 16 weeks after treatment
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.	Baseline, 8 weeks after treatment, and 16 weeks after treatment
ADAS-Cog14	Total scores range from 0 to 90, with higher scores indicating more worsening.	Baseline, 16 weeks after treatment

Collaborators and Investigators

• Sponsor: Rowan

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MCI; Digital Therapeutics; SUPERBRAIN; SUPERBRAIN DEX; DEX
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: RW-MCI-01; ROWAN (Other Identifier: ROWAN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No