None listed
Conditions
Interventions
Medical Device : Participant Selection and Randomization
Participants are screened for eligibility using blood tests, brain imaging, questionnaires, and cognitive function assessments according to the
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 55 to 90 years. 2. Diagnosed with probable Alzheimer’s disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia, 3. or mild cognitive impairment/very mild Alzheimer’s disease with CDR 0.5–1 and MMSE-II =18. 4. On stable cognitive therapy medications for at least 1 month. 5. Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.). 2. Patients with uncontrolled metabolic disorders such as thyroid dysfunction, hypoglycemia, or hepatic/renal impairment, or those on long-term medications that may cause cognitive impairment (e.g., anticholinergic drugs). 3. Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline. 4. Patients with psychiatric disorders outside of the inclusion criteria. 5. Patients with a history of severe diseases such as cancer or tuberculosis. 6. Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system. 7. Patients with contact dermatitis or other skin hypersensitivity conditions. 8. Patients with fever = 40°C as measured by tympanic temperature. 9. Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs. 10. Patients unable to undergo MRI. 11. Pregnant patients. 12. Patients with clinical brain calcification observed on computed tomography (CT) scans. 13. Patients with known allergies to contrast agents such as Definity or Gadovist. 14. Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Trail Making Test-A Completion Time | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in total score of Attention Questionnaire Scale (AQS);Change from baseline at Week 5 after device application in Neuropsychiatric Inventory (NPI) scores;Change from baseline at Week 5 after device application in total score of Quality of Life-Alzheimer's Disease (QoL-AD);Change from baseline at Week 5 after device application in total score of Mini-Mental State Examination 2nd edition (MMSE-II);Change from baseline at Week 5 after device application in Trail Making Test–B (TMT-B) completion time;Quantitative change from baseline at Week 5 after device application in ß-amyloid on Amyloid PET-CT;Change from baseline at Week 5 after device application in plasma biomarkers: phosphorylated tau (p-tau; e.g., pTau181, pTau217, pTau231), amyloid beta (Aß42/Aß40), neurofilament light (NfL), glial fibrillary acidic protein (GFAP);Change from baseline at Week 5 after device application in total score of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog);Change from baseline at Week 5 after device application in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score;Change from baseline at Week 5 after device application in total score of EuroQol 5-Dimensions 5-Level (EQ-5D-5L) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Sook Ahn
Seoul National University Bundang Hospital
Outcome results
None listed