Alzheimer DiseaseTranscranial Magnetic StimulationCerebellum
Investigational drug(s) / intervention(s)
Intermittent Theta-Burst Transcranial Magnetic Stimulation
Intermittent Theta-Burst Transcranial Magnetic Stimulation: 50Hz, stimulation intensity of 100% RMT, duration of 40s as a group of stimulation, 600 stimulation pulses, repeated stimulation of bilateral cerebellar dentate nuclei, with a 5-minute interval between each group, 1200 stimulation pulses per site, 5 times a week, treatment for 4 weeks, then treat once a week for 8 weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age: 50-85 years old
2. 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)
3. MMSE score ranges from 18-26 points; CDR score 0.5-1 points
4. 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
5. At least one adult caregiver
6. The patient or legal guardian voluntarily signs the informed consent form
Exclusion Criteria:
1. Neurodegenerative disorders other than AD.
2. Significant intracranial focal or vascular pathology seen on brain MRI scan
3. History of seizure (with the exception of febrile seizures in childhood)
4. 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)
5. GDS score ≥ 8 points in baseline assessment
6. Cerebrovascular disease, severe infection, malignant tumor, or severe dysfunction of organs such as heart, liver, and kidney.
7. Pregnant or lactating women
8. Contraindications for TMS or MRI, metal or implanted devices in the body (such as pacemakers, deep brain stimulators).
9. Participate in AD related clinical trials within 6 months prior to research registration
Primary outcome measure(s)
The changes in CDR-SB（Clinical Dementia Rating-Sum of Boxes） — baseline, 12 weeks after start of the treatment The changes in CDR-SB will constitute the major research outcome measure used to assess response to rTMS.There are two scoring methods for the CDR scale, namely Total Score Calculation (CDR-GS) and Sum of Six Content Calculation (CDR-SB). The scoring method used in this study is CDR-SB, with a total score of 18 points. The lower the score, the milder the symptoms
Trial sites (4)
Facility
City
Region
Status
Xijing Hospital of Air Force Military Medical University
Xi'an
Shaanxi
Recruiting
Tangdu Hospital of Air Force Military Medical University
Xi'an
Shannxi
Recruiting
The First Affiliated Hospital of Xi'an Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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