RecruitingNot ApplicableNCT06669182

Advantage of Cerebellar Transcranial Magnetic Stimulation in Alzheimer's Diseases （ACT-AD）

Effects of Cerebellar Transcranial Magnetic Stimulation on Patients With Alzheimer's Disease：A Multicenter Randomized Controlled Trial

Sponsor

Xijing Hospital

Enrollment

100 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Transcranial Magnetic Stimulation Cerebellum

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

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria6

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 Criteria12

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

Interventions

DEVICEIntermittent 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.