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NCT Number: NCT07324161

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

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.

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Key information

Conditions

Alzheimer s Disease

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Accelerated rTMS

Device

Accelerated rTMS (iTBS)was delivered using a Cool-B65 A/P coil with individualised positioning. Stimulation intensity was set at 80% of the motor threshold. Each iTBS burst consisted of three pulses delivered at 50 Hz, with bursts repeated at 5 Hz. Stimulation was delivered in 2-s trains separated by 28-s intervals, with a total of 1,600 pulses administered over approximately 20 min. Treatment was applied once daily, 5 days per week, for two consecutive weeks. Consolidation therapy was subsequently administered once weekly for 6 months.

Primary outcomes

  1. MoCA Changes from baseline to post-treatment

    Time frame: Baseline vs 2 weeks and 6 months after treatment

    Montreal Cognitive Assessment (MoCA)

Secondary outcomes

  1. CDR Changes from baseline to post-treatment

    Time frame: Baseline vs 2 weeks and 6 months after treatment

    Clinical Dementia Rating (CDR)

  2. ACE-III Changes from baseline to post-treatment

    Time frame: Baseline vs 2 weeks and 6 months after treatment

    Addenbrooke's Cognitive Examination III

  3. MMSE Changes from baseline to post-treatment

    Time frame: Baseline vs 2 weeks and 6 months after treatment

    Mini-Mental State Examination (MMSE)

  4. NPI Changes from baseline to post-treatment

    Time frame: Baseline vs 2 weeks and 6 months after treatment

    Neuropsychiatric Inventory (NPI)

  5. Neuropathological markers Change from baseline to post-treatment

    Time frame: Baseline vs 2 weeks and 6 months after treatment

    Aβ, tau, GFAP, NFL, VEGF

  6. 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)

  7. fNIRS

    Time frame: Baseline vs 2 weeks and 6 months after treatment

    functional near-infrared spectroscopy

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Pan

CONTACT

[email protected]

13395080173

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 7, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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