Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Alzheimer's Disease

Fujian Medical University (FJMU)

Status: Enrolling

Conditions: Alzheimer s Disease

Treatments: Device: rTMS; Device: sham rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT07324161

rTMS

Details and patient eligibility

About

This study is grounded in the regulatory mechanisms of the glymphatic system and applies repetitive transcranial magnetic stimulation (rTMS) to the treatment of Alzheimer's disease (AD). The clinical efficacy and safety of rTMS will be systematically evaluated. Furthermore, transcranial magnetic stimulation-evoked potentials (TMS-EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to investigate, from the perspectives of synaptic plasticity and neurovascular coupling, the mechanisms by which rTMS influences glymphatic function. Collectively, this work aims to provide new insights into both the therapeutic effectiveness and the underlying mechanisms of rTMS in AD.

Enrollment: 66 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets the 2018 NIA-AA diagnostic criteria for Alzheimer's disease (AD)
• Meets DSM-5 diagnostic criteria
• Mild to moderate disease severity (CDR Global Score 1 to 2)
• Evidence of AD pathology: positive amyloid PET OR positive cerebrospinal fluid (CSF) AD biomarkers OR positive plasma AD biomarkers

Exclusion criteria

• Contraindications to rTMS treatment
• Severe complications or immune diseases
• Unable to cooperate with study procedures
• History of epilepsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups

rTMS

Experimental group

Treatment:

Device: rTMS

sham rTMS

Sham Comparator group

Treatment:

Device: sham rTMS