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

What this Trial Is About

Alzheimer's disease (AD) is a leading cause of dementia characterized by progressive cognitive decline. This trial investigates the use of cerebellar intermittent theta-burst stimulation (CRB-iTBS) to improve cognitive function in people with mild Alzheimer's disease. Researchers aim to assess the treatment's safety and effectiveness in changing the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score over three months, offering a potential new therapy to improve quality of life for those affected. Participants will be randomly assigned to receive either active CRB-iTBS or a sham version. The active treatment involves daily stimulation sessions for four weeks, followed by once-weekly sessions for eight weeks, targeting the bilateral cerebellar dentate nuclei. This noninvasive brain stimulation is delivered using a device with specific parameters including 50Hz frequency and 100% resting motor threshold intensity. The study is double-blind, meaning neither participants nor researchers know which treatment is given, ensuring unbiased results. During the study, participants will undergo assessments including cognitive tests like the Mini Mental State Examination (MMSE), activities of daily living, neuropsychiatric inventory, and brain MRI scans at various points up to 36 weeks. Researchers will monitor changes in cognition and brain function while tracking safety and treatment adherence. The entire participation spans over several months with evaluations at baseline, 12, 24, and 36 weeks to understand short- and longer-term effects.

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