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

January 13, 2026 updated by: Fujian Medical University Union Hospital

Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in the Treatment of Alzheimer's Disease and Exploration of Glymphatic Mechanisms

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • rTMS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS
Device: rTMS
Stimulation coil Cool-B65 A CO, positioning individualised, stimulation frequency 20Hz, stimulation intensity 100% of motor threshold, stimulation number 40 pulses/train, train interval 28s, 40 trains, 1600 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week.Consolidation therapy was also administered weekly for 6 months.
Sham Comparator: sham rTMS
Device: sham rTMS
Stimulation coil Cool-B65 P CO, positioning individualised, stimulation frequency 20Hz, stimulation intensity 100% of motor threshold, stimulation number 40 pulses/train, train interval 28s, 40 trains, 1600 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA Changes from baseline to post-treatment
Time Frame: Baseline vs 2 weeks and 6 months after treatment
Montreal Cognitive Assessment (MoCA)
Baseline vs 2 weeks and 6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDR Changes from baseline to post-treatment
Time Frame: Baseline vs 2 weeks and 6 months after treatment
Clinical Dementia Rating (CDR)
Baseline vs 2 weeks and 6 months after treatment
MMSE Changes from baseline to post-treatment
Time Frame: Baseline vs 2 weeks and 6 months after treatment
Mini-Mental State Examination (MMSE)
Baseline vs 2 weeks and 6 months after treatment
NPI Changes from baseline to post-treatment
Time Frame: Baseline vs 2 weeks and 6 months after treatment
Neuropsychiatric Inventory (NPI)
Baseline vs 2 weeks and 6 months after treatment
Neuropathological markers Change from baseline to post-treatment
Time Frame: Baseline vs 2 weeks and 6 months after treatment
Aβ, tau, GFAP, NFL, VEGF
Baseline vs 2 weeks and 6 months after treatment
TMS-EEG Changes from baseline to post-treatment
Time Frame: Baseline vs 2 weeks and 6 months after treatment
Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG)
Baseline vs 2 weeks and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Estimated)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • rTMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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