None listed
Conditions
Interventions
Medical Device : This study uses gamma-frequency transcranial alternating current stimulation (Gamma-tACS) as the intervention.
Device Name: INNK (by Neurofit Co., Ltd.)
Stimulation Type: Alternating
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals who have received a clinical diagnosis of mild cognitive impairment at the Dementia Clinic of the Department of Psychiatry, Seoul National University Hospital prior to the screening date, and who wish to participate in this study, will be eligible if they meet all of the following criteria: 1. Age: 60 years or older 2. Education: At least 0 years of formal education (must be able to read and write) 3. Confirmed diagnosis of Alzheimer’s disease based on a positive amyloid-ß deposition result from amyloid PET imaging, as recorded in the electronic medical records of Seoul National University Hospital 4. No initiation or dosage change of any anti-dementia medications (limited to donepezil, rivastigmine, galantamine, memantine, or lecanemab) within the past month
Exclusion criteria
Exclusion criteria: Individuals who meet any of the following criteria will be excluded from study participation: 1. Has received a clinical diagnosis of dementia at the Dementia Clinic of the Department of Psychiatry, Seoul National University Hospital prior to the screening date 2. Is currently taking lecanemab as an anti-dementia medication 3. Has physical or mental conditions that would make participation in the intervention or assessments difficult (e.g., advanced cancer, severe internal medical illnesses, delirium, significant visual or hearing impairment) 4. Has a history of traumatic brain injury with documented findings on neuroimaging 5. Has a history of neurological injury including stroke, brain tumor, encephalitis, or hydrocephalus 6. Has a history of epilepsy 7. Has metallic implants in the brain 8. Has implanted electrical devices in the body 9. Is currently participating in another drug or non-drug clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in memory performance (based on Consortium to Establish a Registry for Alzheimer’s Disease – Korean version neuropsychological battery(CERAD-K-NP) subtests, Wechsler Memory Scale – Fourth Edition, Logical Memory(WMS-IV Logical Memory), and Rey Complex Figure Test – Recall(RCFT-Recall)) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in global cognitive function (based on Mini-Mental State Examination – Korean version(MMSE-KC), Consortium to Establish a Registry for Alzheimer’s Disease – Korean version neuropsychological battery total score(CERAD-K-NP total score));Electroencephalogram(EEG) activity changes;Changes in blood biomarkers (Aß40, Aß42, p-tau 181, 217, NFL, GFAP);Instrumental Activities of Daily Living (IADL), Geriatric Depression Scale | — |
Countries
Korea, Republic of
Contacts
Public ContactSunghoon Chung
Seoul National University Hospital
Outcome results
None listed