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

NCT ID: NCT07324161

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-16

Study Completion Date

2029-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer s Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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rTMS

Group Type EXPERIMENTAL

rTMS

Intervention Type 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

Group Type SHAM_COMPARATOR

sham rTMS

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University Union Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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rTMS

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaodong Pan

Role: CONTACT

13395080173

Facility Contacts

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Xiaodong Pan

Role: primary

059186218340

Other Identifiers

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rTMS

Identifier Type: -

Identifier Source: org_study_id

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