Alzheimers disease
Conditions
Interventions
Intervention group:Personalized Closed-Loop Neuromodulation Intervention
Sponsors
Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 50-85 years, regardless of gender; 2. Meeting the NIA-AA (2018 edition) diagnostic criteria for Alzheimer's disease, with a clinical diagnosis of mild Alzheimer's disease; 3. Clinical Dementia Rating (CDR) global score of 0.5 or 1.0; 4. Mini-Mental State Examination (MMSE) score between 18 and 26 (inclusive); 5. Montreal Cognitive Assessment (MoCA) score = 20; 7. Presence of clear episodic memory impairment (delayed recall score more than 1.5 standard deviations below age- and education-matched norms) or attention deficit (reaction time in attention network test prolonged by >= 2 standard deviations); 8. Possessing basic reading, writing, and communication abilities, capable of cooperating with cognitive assessments and stimulation interventions; 9. Able to tolerate EEG electrode placement and transcranial electrical/magnetic stimulation, with no history of skin allergies or discomfort; 10. Able to understand the study content and sign a written informed consent form, voluntarily participating in this study.
Exclusion criteria
Exclusion criteria: 1. Any neurological diseases other than Alzheimer's disease that may cause cognitive impairment (such as Parkinson's disease, frontotemporal dementia, dementia with Lewy bodies, Huntington's disease, multiple sclerosis, brain tumors, normal pressure hydrocephalus, epilepsy, etc.); 2. Severe depression (Hamilton Depression Scale HAMD-17 score >= 24) or other serious mental illnesses; 3. History of severe traumatic brain injury (accompanied by loss of consciousness for more than 30 minutes or resulting in neurological deficits); 4. Severe cardiac, hepatic, or renal insufficiency (e.g., Child-Pugh class C cirrhosis, eGFR < 30 mL/min/1.73 m^2); 5. Presence of metal implants in the head (such as aneurysm clips, cochlear implants, etc.), cardiac pacemakers, or other electrically sensitive implantable medical devices; 6. History of severe adverse reactions during previous TMS treatment (e.g., induced seizures); poorly controlled epilepsy currently, defined as: breakthrough seizures while on antiepileptic drugs; history of seizures after the current stroke onset; presence of unhealed skull defects caused by the current stroke; 7. Current use of medications that lower the seizure threshold (e.g., bupropion, clonidine, certain antipsychotics, etc.); 8. Patient unable to express their own sensations (e.g., severe disturbance of consciousness, aphasia, cognitive impairment preventing cooperation in reporting discomfort); 9. Received any form of transcranial electrical/magnetic stimulation therapy within the past 6 months; 10. Currently participating in other interventional clinical trials, or participated in other clinical trials within the past 3 months; 11. Known or suspected history of alcohol or drug dependence; 12. Pregnant, lactating, or planning to become pregnant women (women of childbearing age require a pregnancy test during the screening period); 13. Other conditions deemed by the investigator as unsuitable for participation in this trial (e.g., severe visual or hearing impairment affecting assessment, unstable systemic diseases, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-Cog Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| MOCA score;Relative power in the gamma band Theta/gamma power ratio P300 component parameters Visual search efficiency Comprehensive gait balance index; | — |
Countries
China
Contacts
Public ContactPing Luan
Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)
Outcome results
None listed