Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in the Treatment of Alzheimer's Disease and Exploration of Glymphatic Mechanisms
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- MoCA Changes from baseline to post-treatment
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
rTMS
Intervention: rTMS (Device)
sham rTMS
Intervention: sham rTMS (Device)
Outcomes
Primary Outcomes
MoCA Changes from baseline to post-treatment
Time Frame: Baseline vs 2 weeks and 6 months after treatment
Montreal Cognitive Assessment (MoCA)
Secondary Outcomes
- MMSE Changes from baseline to post-treatment(Baseline vs 2 weeks and 6 months after treatment)
- TMS-EEG Changes from baseline to post-treatment(Baseline vs 2 weeks and 6 months after treatment)
- CDR Changes from baseline to post-treatment(Baseline vs 2 weeks and 6 months after treatment)
- NPI Changes from baseline to post-treatment(Baseline vs 2 weeks and 6 months after treatment)
- Neuropathological markers Change from baseline to post-treatment(Baseline vs 2 weeks and 6 months after treatment)