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

Last updated: October 30, 2024
Sponsor: Rowan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Dementia

Alzheimer's Disease

Treatment

Educational book

SB-100

Clinical Study ID

NCT06264557
RW-MCI-01
ROWAN
  • Ages 50-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 impairmentcaused by Alzheimer's disease as of the screening date

  • Concern of the subject or guardian about the deterioration of cognitivefunction compared to before

  • More than one cognitive impairment

  • Maintaining the independence of overall daily life functions

  • It's not dementia

  1. In at least one of the following neuropsychological tests conducted within one yearof 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)

  1. 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 tablecorrected for education level and age as of the screening date

  2. Those with a Global Clinical Dementia Rating (CDR) score of 0.5 and a memory itemscore of 0.5 or 1 as of the screening date

  3. A person who has a guardian in regular contact with the subject

  • Defined to be able to support subjects during the clinical trial (compliancesupervision and subject status reporting) and spend at least 8 hours per weekwith subjects
  1. A person who is taking drugs (donepezil, galantamine, ribastigmine, memantine) forthe purpose of improving cognitive function is taking drugs stably for at least 12weeks as of the screening date

  2. Those who have no difficulty using tablet PCs

  3. A person who voluntarily decides to participate in this clinical trial and agrees tothe subject's explanation and consent in writing

  4. Those who are willing to comply with the clinical trial plan

Exclusion

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 affectingcognitive function within one year of the screening date (e.g., stroke, multiplesclerosis, severe head trauma with loss of consciousness, normal cerebralhydrocephalus, epilepsy, brain tumors, cerebral infarction, spinal cord infarctionor 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 drugaddiction and alcoholism

  4. Laboratory and/or vital signs tests as of the date of screening, any of thefollowing

  • Those diagnosed with infectious or metabolic diseases that may cause cognitivedecline in the subject (e.g., hypothyroidism, vitamin B12 deficiency, folatedeficiency, neurotoxin, HIV)

  • Those with liver dysfunction (AST, ALT ≥ 3x upper limit of normal range) and/orrenal dysfunction (serum creatinine ≥ 2x upper limit of normal range)

  • Those with uncontrolled hypertension (SBP > 180 mmHg) and/or diabetes (HbA1c > 11%)

  1. Those who have severe or unstable cardiovascular disease (e.g., myocardialinfarction, unstable angina, class III or IV heart failure by classification of theNew York Heart Association (NYHA) within 24 weeks of the screening date)

  2. Where the tester determines that he/she has a medical condition that may interferewith the completion of the clinical trial due to a serious or unstable physicalcondition (e.g., a history of malignant tumors within five years of the screeningdate (e.g., basal cell cancer and squamous cell carcinoma of the skin considered tohave been completely resected and cured, cervical intraepithelial carcinoma,non-transparent prostate cancer, acute and severe asthma, active peptic ulcers,etc.)

  3. If you can't walk, A person who can move using walking aids (e.g. walkers, canes,wheelchairs, etc.)

  4. an illiterate patient who is unschooled (defined as unadmitted to a regular school)

  5. Where the tester determines that a person does not have sufficient vision, hearing,language skills, motor skills, and comprehension to follow the examinationprocedures related to clinical trials

  6. a person who is pregnant or nursing

  7. For women of childbearing age, who do not agree with the medically permittedcontraceptive method during the clinical trial

  • Hormonal contraception, intrauterine device (IUD) or intrauterine system (IUS),oviduct ligation, double blocking (male condom, female condom, cervical cap, acombination of contraceptive septum, contraceptive sponge-like blockingmethods), a single blocking method with a combination of an alveolar agent
  1. Those who are currently participating in other clinical trials or who haveparticipated in other clinical trials within 90 days of screening

  2. Other, ethical or clinical trial outcomes may be impacted and deemed inappropriateby the tester

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Educational book
Phase:
Study Start date:
January 17, 2024
Estimated Completion Date:
June 30, 2025

Study 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

Connect with a study center

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do 11923
    Korea, Republic of

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hospital

    Kwangju,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Koera University Guro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

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

    Suwon,
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.