Alzheimer's Disease
Conditions
Interventions
Treatment group:Transcranial Pulse Stimulation
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 50 years old to 85 years old, gender not restricted; 2.Adhering to the diagnostic criteria for Alzheimer's disease proposed by the National Institute on Aging and Alzheimer's Association of the United States (NIA-AA) in 2024, with the disease severity at stages 3-5. If there is no previous evidence of AD pathology or biological markers, before enrollment, the subjects must have one positive core biomarker among the following: amyloid protein (Aß) PET, cerebrospinal fluid Aß42/40 ratio, p-tau181/Aß42 ratio or t-tau/Aß42 ratio, plasma p-tau217, or a combination of these indicators; 3.0.5 point <= total score of the Clinical Dementia Rating Scale (CDR-GS) <=2 points; 4. 11 points <=Mini-Mental State Examination (MMSE) score <= 26 points, where 11 points <=university <= 26 points, 11 points <= middle school <= 24 points, 11 points <= primary school <=23 points; 5. Hachinski Ischemia Scale (HIS) score <= 4 points; 6.The subjects or family members voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Refusal or failure to sign the informed consent form; 2. Memory and cognitive decline not caused by AD, such as when diagnosed with other types of dementia, including but not limited to vascular dementia (VD), Parkinsonian dementia (PDD), Lewy body dementia (DLB), etc.; endocrine system disorders (such as thyroid diseases), as well as dementia caused by folic acid, vitamin B12 deficiency or any other reason; dementia caused by alcohol dependence or drug dependence; presence of consciousness disorders, etc.; 3. Severe dysfunction of important organs (heart, lungs, liver, kidneys, etc.), such as liver dysfunction (transaminase exceeding the upper limit of normal by more than 3 times), kidney dysfunction (creatinine, urea nitrogen exceeding the upper limit of normal by more than 1.5 times or creatinine clearance rate < 45 ml/min), abnormal coagulation function, etc.; serious diseases requiring treatment and threatening life (malignant tumors of various systems, acute cardiovascular and cerebrovascular diseases, etc.); 4.Mental system diseases such as schizophrenia, affective disintegrative mental disorders, bipolar affective disorder, severe anxiety or depression; 5.MRI examination shows multiple intracranial microbleeds and other hemorrhagic lesions; 6.Glucocorticoid treatment was administered within the last 6 weeks before the first treatment; 7. Participants were enrolled in this trial within 3 months before or are currently participating in other interventional clinical trials; 8. Unable to cooperate with corresponding diagnosis and treatment or have contraindications for Transcranial Pulse Stimulation treatment; 9.Pregnant or lactating women; 10. Those judged by the investigator to be unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the score of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the score of the Clinical Dementia Rating;The change in the score of the Mini-Mental State Examination;The change in the score of the Montreal Cognitive Assessment;The change in the score of the Neuropsychiatric Inventory;Blood biomarkers;MRI;EEG; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital of Sichuan University
Outcome results
None listed