Alzheimers disease
Conditions
Interventions
Sham Group:Participants underwent the same electrode placement and initial current ramping protocol as the treatment group. Once a tingling sensation was reported, the current was reduced to below the
20 Hz Group:The electrode was placed on the left tragus. The pulse width was 200 µs, the frequency was 20 Hz, and each session lasted 30 minutes. During the first 30 seconds, the current intensity was
thereafter, the intensity was adjusted to a level slightly below the individual’s sensory threshold and remained constant for the remainder of the stimulation period. Sessions were conducted once a da
40 Hz Group:The electrode was placed on the left tragus. The pulse width was 200 µs, the frequency was 40 Hz, and each session lasted 30 minutes. During the first 30 seconds, the current intensity was
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Referring to the "Revised criteria for diagnosis and staging of Alzheimer’s disease: Alzheimer’s Association Workgroup" issued by the National Institute on Aging and the Alzheimer’s Association in 2024, participants will be classified as clinical Stage 4 or Stage 5 according to clinical staging criteria; 2. Participants must meet at least one of the following biological diagnostic criteria: abnormal amyloid PET; abnormal cerebrospinal fluid Aß42/40, cerebrospinal fluid p-tau181/Aß42, or cerebrospinal fluid t-tau/Aß42; or abnormal plasma p-tau 217; 3. Male or female, aged 55–85 years; 4. Long-term resident of the local area; 5. Right-handed; 6. Has not participated in any other clinical trials within 1 month prior to enrollment; 7. Alert, emotionally stable, and capable of performing simple reading, arithmetic, writing, and daily communication; 8. The subject or their family voluntarily agrees to participate in the clinical study and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with cognitive impairment caused by cerebrovascular disease or other factors (such as vascular dementia, hypoxic-ischemic encephalopathy, frontotemporal atrophy, multiple system atrophy, etc.); 2. Individuals with severe systemic diseases, such as malignant tumors, immune system disorders, liver failure, kidney failure, or cardiopulmonary failure; 3. Individuals with severe neurological impairments, such as hemiplegia, epilepsy, aphasia, deafness, or blindness; 4. Individuals with mental disorders such as anxiety or depression, those on long-term psychiatric medication, or those with HAMD and HAMA scores =7; 5. Metabolic disorders, including anemia, thyroid dysfunction, and folate and vitamin B12 deficiencies, which may lead to cognitive decline; 6. Idividuals exposed to chemical toxins, severe viral infections, or bacterial infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) scores from baseline to the end of treatment at Week 12.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in scores on the Alzheimer's Disease Assessment Scale—Cognitive Subscale from baseline to the follow-up time points at weeks 24 and 36.;Changes from baseline to each follow-up time point (Week 12, Week 24, Week 36) in the following measures from the Alzheimer’s Disease Cooperative Study–Activities of Daily Living Inventory (ADCS-ADL), Clinical Dementia Rating–Sum of Boxes (CDR-SB), Auditory Verbal Learning Test–Huashan version (AVLT-H), Digit Span Test (DST), Neuropsychiatric Inventory (NPI), and Zarit Burden Interview (ZBI).;Changes in serum immune markers (IL-1ß, IL-6, TNF-a, IL-10) from baseline to the end of treatment at Week 12.;Changes in blood biomarkers (p-tau217, GFAP) from baseline to the end of treatment at Week 12.;Heart Rate Variability (HRV): Changes in the standard deviation of all normal R-R intervals (SDNN), the root mean square of successive R-R interval differences (RMSSD), and the low-frequency/high-frequency power ratio (LF/HF) at baseline and at the end of the 12-week intervention.;Changes in the mean resting-state functional connectivity within the Default Mode Network (DMN) from baseline to the end of treatment at Week 12.;The change in the mean value of HbO activation in the prefrontal cortex from baseline to the end of treatment at Week 12.;The change from baseline to week 12 in task-related gamma-band power centered at 40 Hz during the n-back working memory task. ; | — |
Countries
China
Contacts
Public ContactShi Yixing
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed