Investigation of improvement in cognitive function after transcranial direct current stimulation in mild cognitive impairment
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0009708
- Lead Sponsor
- Ybrain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 190
1) Adults men or women between 55 and 90 years of age
2) Meet the following according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic guidelines published in 2011
All of the following core clinical criteria for Mild cognitive impairment due to Alzheimer's disease* must be met
- Concern about previous functional changes
- Impairment in one or more of cognitive domains
- Maintained independence in overall daily living functioning
- Absence of dementia
* Subjects diagnosed with mild cognitive impairment due to Alzheimer's disease by tests such as MRI (magnetic resonance image) and/or FDG-PET (F-18 fluorodeoxyglucose Positron Emission Tomography). However, if not diagnosed at Screening, subjects must be diagnosed with mild cognitive impairment due to Alzheimer's disease by MRI and/or FDG-PET prior to Visit 2.
3) Mild cognitive impairment with MMSE (Mini Mental State Examination) score of 23 or higher
4) CDR (Clinical Dementia Rating) global score not more than 0.5 or GDS (Global Deterioration Scale) score not more than 3
5) Those who satisfy the following regarding medications received prior to screening
?. Acetylcholinesterase inhibitors (ACEIs), NMDA receptor inhibitors (NMDA receptor inhibitors) have been taken at the same dose and regimen for at least 3 months prior to the screening date; or, drugs for the treatment of cognitive function other than ACEIs and NMDA receptor antagonists have been taken at the same dose and regimen for at least 1 month prior to the screening date.
?. For patients taking antidepressants and medications for the treatment of chronic diseases including hypertension, diabetes, hyperlipidemia, thyroid disease, etc.
6) Able to read and understand the study consent form and is capable of language proficiency at a level capable of answering the questionnaires
7) Able to voluntarily decide on participation and provide written consent, and can participate in the entire period of the clinical trial
1) Diagnosis of dementia (neurocognitive disorder) based on DSM-? (Diagnostic and Statistical Manual, fifth edition) or ICD-10 (The International Statistical Classification of Disease and Related Health Problems)
2) Patients have cognitive deficits due to following diseases: Parkinson's disease, Huntington disease, subdural hemorrhage, central nervous system infections (HIV, syphilis), thyroid disease, deficiency of vitamin V12 or folic acid
3) History of axis ? psychiatric disorders including intellectual disabilities, schizophrenia, alcohol addiction, and bipolar disorder
4) History of convulsion within 5 years of the screening date
5) Those who meet the criteria below through CT or MRI within 1 year of the screening date
- Acute or subacute hemorrhage
- If unable to document that previous massive hemorrhage (defined as diameter > 1 cm on T2 sequence) or previous sub-arachnoid hemorrhage was not due to underlying structural or vascular abnormalities (i.e., findings do not suggest a risk of relapse for the subject)
- Four or more minor hemorrhage (defined as not more than 1 cm in diameter on T2 sequence)
- Any cortical infarct or single subcortical infarct greater than 1.5 cm in diameter (In case of diffusion weighted image, more than 2 cm)
- Superficial siderosis
- History of diffuse white matter disease defined as a score of 3 on the scale of age-related white matter change
- According to the investigator, any findings that might contribute to dementia, endager the subject, or could interfere with MRI assessment for safety monitoring
* MRI imaging will be Gradient Echo Sequence or Susceptibility-weighted image (SWI) or Diffusion-weighted image (DWI), if no CT or MRI results are available within 1 year of screening to confirm the presence of brain disease.
6) Those who have cerebral injury due to trauma, ischemia, hypoxia, etc.
7) Those who have been admitted to the hospital for mental illness within 5 years of the screening date
8) Those who have abused drugs within 5 years of the screening date
9) Those who have been treated for alcohol addiction within 5 years of the screening date
10) Difficulty reading the text even with glasses due to decreased vision
11) Difficulty understanding conversations even with hearing aid due to hearing impairment
12) Difficulty breathing while sitting still
13) Suicide attempt within the previous 6 months prior to the screening date
14) Problems with electroencephalograms and transcranial direct current stimulation electrodes due to scalp deformities, inflammatory reactions, or other skin problems
15) Any other contraindication to the use of a tDCS medical device (e.g., metal plates in the head, etc.)
16) Participation in other clinical trials within 30 days from the screening date
17) Participation in other clinical trials for mild cognitive impairment due to Alzheimer's disease or early dementia within 1 year from the screening date
18) Female subjects of childbearing potential who do not consent to using contraception* in a medically acceptable manner during this trial
**Medically accepted contraceptive methods: condoms, oral contraception for at least 3 months or more, using injectable or injectable contraceptives, installing intrauterine contraceptives, etc.)
19) Pregnant or breastfeeding women
20) In addition to the above, those who are judged to be inadequate for participating in the clinical trial by a principal investigator or the person in charge
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in ADAS-Cog 11(Alzheimer's Disease Assessment Scale-Cognitive Subscale 11) score;Changes in K-MMSE(Mini Mental State Examination) score
- Secondary Outcome Measures
Name Time Method Changes in MoCA-K(Korean version of Montreal cognitive Assessment) score;Changes in K-IADL(Korean-Instrumental Acrivities of Daily Living) score;Changes in CDR(Clinical Dementia rating) score;Changes in SNSB-?(Seoul Neuropsychological Screening Battery ?) subtests score;Changes in NPI(Neuropsychiatric Inventory) score;Changes in Oligomeric Amyloid Beta in blood measured chemiluminescence immunoassay