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

NCT07324161 | Recruiting

• 1 other identifier: rTMS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer s Disease

Outcome Measures

Primary Outcomes (1)

• MoCA Changes from baseline to post-treatment

  Montreal Cognitive Assessment (MoCA)

  Baseline vs 2 weeks and 6 months after treatment

Secondary Outcomes (5)

• CDR Changes from baseline to post-treatment

  Baseline vs 2 weeks and 6 months after treatment

• MMSE 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

• TMS-EEG Changes from baseline to post-treatment

  Baseline vs 2 weeks and 6 months after treatment

Study Arms (2)

rTMS

EXPERIMENTAL

Device: rTMS

sham rTMS

SHAM COMPARATOR

Device: sham rTMS

Interventions

rTMS DEVICE

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.

rTMS

sham rTMS DEVICE

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

sham rTMS

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

rTMS

Fuzhou, Fujian, 350001, China

RECRUITING

Central Study Contacts

Xiaodong Pan

CONTACT

13395080173; panxd@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: April 16, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)