Clinical trial NCT06264557: Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
MCI
Keywords: SUPERBRAIN
SUPERBRAIN DEX
DEX
MCI
Digital Therapeutics
Lead sponsor: Rowan
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment

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

Eligibility criteria: 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

Primary outcomes:
measure: K-RBANS
timeFrame: Baseline, 16 weeks after treatment
Secondary outcomes:
measure: K-RBANS
timeFrame: Baseline, 8 weeks after treatment
measure: K-MMSE-2
timeFrame: Baseline, 8 weeks after treatment, and 16 weeks after treatment
measure: CDR-SB
timeFrame: Baseline, 8 weeks after treatment, and 16 weeks after treatment
measure: K-IADL
timeFrame: Baseline, 8 weeks after treatment, and 16 weeks after treatment
measure: PRMQ
timeFrame: Baseline, 8 weeks after treatment, and 16 weeks after treatment
measure: GDS-15
timeFrame: Baseline, 8 weeks after treatment, and 16 weeks after treatment
measure: QOL-AD
timeFrame: Baseline, 8 weeks after treatment, and 16 weeks after treatment
measure: ADAS-Cog14
timeFrame: Baseline, 16 weeks after treatment
Other outcomes:
Locations:
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Kwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Koera University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
Study officials:
References: