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

Mild Cognitive Impairment Clinical Trial

— SB-DEX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264557
• Other study ID #: RW-MCI-01
• Secondary ID: ROWAN
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2024
• Source: Rowan
• Contact: Hyunsung Yoon
• Phone: 010-5544-0970
• Email: yswon111[@]rowan.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: May 1, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• MCI
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Chonnam National University Hospital	Kwangju
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Koera University Guro Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Rowan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ADAS-Cog14	Total scores range from 0 to 90, with higher scores indicating more worsening.	Baseline, 16 weeks after treatment