Phase
Condition
Mild Cognitive Impairment
Dementia
Alzheimer's Disease
Treatment
Educational book
SB-100
Clinical Study ID
Ages 50-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 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
- 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)
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
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
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
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
Those who have no difficulty using tablet PCs
A person who voluntarily decides to participate in this clinical trial and agrees tothe subject's explanation and consent in writing
Those who are willing to comply with the clinical trial plan
Exclusion
Exclusion Criteria:
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 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)
Based on the screening date, major depressive disorder, bipolar disorder,schizophrenia, A person diagnosed with a serious mental illness such as drugaddiction and alcoholism
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%)
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)
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.)
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 examinationprocedures related to clinical trials
a person who is pregnant or nursing
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
Those who are currently participating in other clinical trials or who haveparticipated in other clinical trials within 90 days of screening
Other, ethical or clinical trial outcomes may be impacted and deemed inappropriateby the tester
Study Design
Study Description
Connect with a study center
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do 11923
Korea, Republic ofActive - Recruiting
Inje University Haeundae Paik Hospital
Busan,
Korea, Republic ofActive - Recruiting
Gachon University Gil Medical Center
Incheon,
Korea, Republic ofActive - Recruiting
Inha University Hospital
Incheon, 22332
Korea, Republic ofActive - Recruiting
Chonnam National University Hospital
Kwangju,
Korea, Republic ofActive - Recruiting
Ewha Womans University Seoul Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Hanyang University Seoul Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Koera University Guro Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Korea University Anam Hospital
Seoul,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon,
Korea, Republic ofActive - Recruiting
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