Advantage of Cerebellar Transcranial Magnetic Stimulation in Alzheimer's Diseases (ACT-AD)
Recruiting · NCT06669182 · Interventional (participants receive a specific treatment) · Lead sponsor: Xijing Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Alzheimer's Disease (AD) is the primary cause of dementia, with its prominent feature being cognitive decline. The cerebellum plays a crucial role in cognitive processing, making it a potential target for therapeutic intervention. This study will be conducted to evaluate the efficacy and safety of cerebellar Intermittent theta-burst stimulation (CRB-iTBS) in participants with mild Alzheimer's disease on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 3 months of treatment in the Core Study. This project aims to provide a valid treatment to improve the cognitive function and quality of life for those with Alzheimer's disease.
Who can take part
Inclusion criteria
- Age: 50-85 years old
- Meet the core clinical criteria of NIA-AA for possible Alzheimer's disease dementia, and PET or cerebrospinal fluid markers show elevated p-tau and decreased A β (1-42)
- MMSE score ranges from 18-26 points; CDR score 0.5-1 points
- The patient has received treatment with acetylcholinesterase inhibitors (AChEI), NMDA receptor antagonists, or mannequine therapy, and the current dosing regimen has remained stable for the 12 weeks prior to baseline assessment
- At least one adult caregiver
- The patient or legal guardian voluntarily signs the informed consent form
Exclusion criteria
- Neurodegenerative disorders other than AD.
- Significant intracranial focal or vascular pathology seen on brain MRI scan
- History of seizure (with the exception of febrile seizures in childhood)
- Any of the following psychotic disorders (DSM IV-TR criteria):
- Major depressive disorder (current)
- Schizophrenia
- Other psychotic disorders, bipolar disorder, or substance related disorders (within the past 5 years)
- GDS score ≥ 8 points in baseline assessment
- Cerebrovascular disease, severe infection, malignant tumor, or severe dysfunction of organs such as heart, liver, and kidney.
- Pregnant or lactating women
- Contraindications for TMS or MRI, metal or implanted devices in the body (such as pacemakers, deep brain stimulators).
- Participate in AD related clinical trials within 6 months prior to research registration
Where it is running
4 locations listed.
- Xijing Hospital of Air Force Military Medical University - Xi'an, Shaanxi, China
- Tangdu Hospital of Air Force Military Medical University - Xi'an, Shannxi, China
- The First Affiliated Hospital of Xi'an Medical University - Xi'an, Shannxi, China
- The Third Hospital of Xi'an - Xi'an, Shannxi, China