Alzheimer's Disease and Mild Cognitive Impairment
Conditions
Interventions
active tACS group for MCI:Stimulation Frequency: 6Hz (theta oscillation)
Current Intensity: 2mA
Target:Medial Prefrontal Cortex (mPFC)
Stimulation Duration: 20 minutes per day for 10 consecutive days
sham tACS group for MCI:Current Intensity: Gradually increasing to 2mA over the first 30 seconds, then immediately dropping to 0mA
Stimulation Duration: 20 minutes per day for 10 consecutive days
active tACS group for AD:Stimulation Frequency: 6Hz (theta oscillation)
sham tACS group for AD:Current Intensity: Gradually increasing to 2mA over the first 30 seconds, then immediately dropping to 0mA
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for MCI Patients: 1. Aged 50 to 85 years; 2. Male or female; 3. Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) as defined by Peterson; 4. Willing to participate and provide written informed consent. **Inclusion Criteria for AD Patients:** 1. Aged 50 to 80 years (inclusive); 2. Male or female; 3. MMSE score >= 10 and <= 24; 4. Clinically diagnosed with probable Alzheimer's disease (AD) according to the NINCDS-ADRDA criteria; 5. Presence of cranial imaging (CT or MRI) findings supporting the diagnosis of AD, and these imaging studies were performed within the past six months or prior to enrollment; 6. For those who have been treated with cholinesterase inhibitors (e.g., Aricept) before baseline, they agree to continue taking cholinesterase inhibitors (e.g., Aricept 10 mg/d) during participation in this study; 7. Any comorbid conditions of the patient must be clinically stable before baseline, with any exceptions requiring separate explanation; 8. Clinical laboratory values must be within the normal range, or if abnormal, must be judged by the investigator to be clinically insignificant; 9. The patient or their legal guardian must sign the informed consent form; 10. The participant must have a family member/caregiver to ensure they can return to the research center for treatment as scheduled and to ensure compliance with the treatment regimen, as well as to monitor for any potential adverse effects.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for MCI Patients: Severe neurological disorders (e.g., Parkinson’s disease, vascular dementia, etc.); Severe somatic diseases or psychiatric disorders; Participation in other clinical trials within the past three months; use of cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonists, antipsychotics, sedative-hypnotics, antidepressants, etc., on a daily basis within the past 30 days; Presence of severe sensory or motor impairments that could affect cognitive assessment. Exclusion Criteria for AD Patients: Known history in the subject of diseases that can affect cognitive function but can be distinguished from AD, such as: schizophrenia, depression, Parkinson’s disease, multi-infarct dementia, dementia caused by cerebrovascular disease, Huntington’s disease, Pick’s disease, corticobasal degeneration (CJD), Lewy body disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, and subjects known to have the following diseases or conditions: human immunodeficiency virus disease, neurosyphilis, or persistent neurological deficits or known structural brain abnormalities after severe head trauma; Presence of active or uncontrolled epilepsy, asthma, central nervous system infections, other neurodegenerative diseases, and other advanced severe progressive unstable diseases; Presence of dementia with other organic diseases, or AD with delirium (according to DSM-IV criteria); Presence of severe disabilities that prevent the subject from meeting the requirements of the clinical study (e.g., blindness, severe deafness preventing communication, severe speech disorders preventing communication); Modified Hachinski Ischemia Score (MHIS) > 4 points; Presence of severe cardiovascular diseases such as serious arrhythmias, or severe hepatic or renal dysfunction; subjects with implanted devices such as pacemakers or deep brain stimulators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| scores of cognitive tests; | — |
Secondary
| Measure | Time frame |
|---|---|
| scores of depression scales;olfactory function;Magnetic resonance imaging;electroencephalogram;activity of daily life;degree of dementia; | — |
Countries
China
Contacts
Public ContactYuping Ning
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed