Cerebellar Transcranial Magnetic Stimulation for Alzheimer's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.