Cerebellar Transcranial Magnetic Stimulation for Alzheimer's Disease
Effects of Cerebellar Transcranial Magnetic Stimulation on Patients With Alzheimer's Disease：A Multicenter Randomized Controlled Trial
This study is testing a new brain stimulation technique to see if it can help improve thinking and daily life for people with mild Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 4 sites (Xi'an, Shaanxi and 3 other locations) |
| Trial ID | NCT06669182 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of cerebellar Intermittent Theta-Burst Stimulation (CRB-iTBS) in patients with mild Alzheimer's disease. It aims to improve cognitive function and quality of life by targeting the cerebellum, which may help compensate for cognitive impairments associated with Alzheimer's. Participants will undergo a randomized, double-blind, sham-controlled intervention to assess changes in cognitive function over three months. The study focuses on the relationship between cerebellar stimulation and cognitive rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50-85 with mild Alzheimer's disease and stable treatment regimens.
Not a fit: Patients with other neurodegenerative disorders or significant intracranial pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new therapeutic option to enhance cognitive function in patients with Alzheimer's disease.
How similar studies have performed: While the approach of targeting the cerebellum for cognitive enhancement is novel, previous studies have shown promise with transcranial magnetic stimulation in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Xi'an, Shaanxi and 3 other locations
- Xijing Hospital of Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)
- Tangdu Hospital of Air Force Military Medical University — Xi'an, Shannxi, China (Recruiting)
- The First Affiliated Hospital of Xi'an Medical University — Xi'an, Shannxi, China (Recruiting)
- The Third Hospital of Xi'an — Xi'an, Shannxi, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.