Alzheimer's Disease
Conditions
Interventions
Intervention Group:High-Intensity Focused Ultrasound Treatment
Sponsors
Shanghai International Medical Center
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Signed and dated informed consent form: The informed consent form must be signed by both the patient and their legal guardian, with identification documents of the guardian and proof of kinship provided; 2.Commitment to comply with study procedures: The patient and guardian jointly agree to cooperate in completing FUS treatment, cognitive assessments, imaging examinations, and the entire follow-up period; 3.Age and gender: Age 55 to 85 years, with no gender restriction; 4.Diagnostic criteria: Diagnosis of Alzheimer’s disease according to the 2018 NIA-AA Alzheimer’s Disease Diagnostic Criteria (National Institute on Aging–Alzheimer’s Association), at a mild to moderate stage with MMSE score < 20; 5.Laboratory and imaging evidence: Positive Aß deposition in the hippocampus and/or frontal lobe on PET-CT, or cerebrospinal fluid (CSF) examination showing an Aß42/Aß40 ratio < 0.06; no acute cerebral infarction, intracerebral hemorrhage, brain tumor or other space-occupying lesions on cranial MRI within the past 3 months; 6.Ability to cooperate with intervention: No swallowing dysfunction (able to take routine medications normally), tolerance of MRI positioning and local anesthesia during FUS treatment, and absence of claustrophobia.
Exclusion criteria
Exclusion criteria: 1.Device / treatment contraindications: Presence of implantable devices such as cardiac pacemaker, deep brain stimulator (DBS), etc.; history of intracranial hemorrhage, cerebral aneurysm, or cerebrovascular malformation; 2.Medication restrictions: Participation in other AD-related clinical trials and use of investigational products within the past 3 months; ongoing use of immunosuppressants or antipsychotic agents (e.g., risperidone) with unstable dosages; inability to discontinue cholinesterase inhibitors / NMDA receptor antagonists (required washout period >= 2 weeks); 3.Acute medical conditions: Febrile illness (body temperature >= 38.5? for > 24 hours) or unresolved acute infection (e.g., pneumonia, urinary tract infection) within the past 1 month; 4.Severe comorbidities: Severe cardiac insufficiency (NYHA Class ?–?), decompensated liver cirrhosis, chronic renal failure (CKD Stage 4–5); history of epilepsy with seizure episodes within the past 1 year; uncontrolled psychiatric disorders including severe depression and schizophrenia; 5.Cognitive / functional impairment: Complete loss of activities of daily living (ADL score = 10 cigarettes per day, or daily alcohol consumption equivalent to >= 20 g of ethanol within the past 6 months(e.g., 500 ml beer or 50 ml Chinese liquor).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination score;Montreal Cognitive Assessment(MoCA) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive Subscale Score; | — |
Countries
China
Contacts
Public ContactBomin Sun
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine/Shanghai International Medical Center
Outcome results
None listed