Alzheimer s DiseaseNCT07324161
Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Alzheimer's Disease
A study testing rTMS and Accelerated rTMS in people with Alzheimer s Disease, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- rTMS and Accelerated rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to rTMS treatment
- Severe complications or immune diseases
- Unable to cooperate with study procedures
- History of epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
rTMS
Fuzhou, Fujian, 350001
Xiaodong Pan, 059186218340, panxd@fjmu.edu.cn
About this study
Official title: 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.
- Conditions
- Alzheimer s Disease
- Being tested
- rTMS, sham rTMS, Accelerated rTMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
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 rTMSDevice
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 rTMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | Not described Receives: Device: rTMS |
| sham rTMS | Sham comparator | Not described Receives: Device: sham rTMS |
| Accelerated rTMS | Active comparator | Not described Receives: Device: Accelerated rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA Changes from baseline to post-treatment
Montreal Cognitive Assessment (MoCA)
Measured: Baseline vs 2 weeks and 6 months after treatment
Secondary outcomes (7)
CDR Changes from baseline to post-treatment
Clinical Dementia Rating (CDR)
Measured: Baseline vs 2 weeks and 6 months after treatment
ACE-III Changes from baseline to post-treatment
Addenbrooke's Cognitive Examination III
Measured: Baseline vs 2 weeks and 6 months after treatment
MMSE Changes from baseline to post-treatment
Mini-Mental State Examination (MMSE)
Measured: Baseline vs 2 weeks and 6 months after treatment
NPI Changes from baseline to post-treatment
Neuropsychiatric Inventory (NPI)
Measured: Baseline vs 2 weeks and 6 months after treatment
Neuropathological markers Change from baseline to post-treatment
Aβ, tau, GFAP, NFL, VEGF
Measured: Baseline vs 2 weeks and 6 months after treatment
TMS-EEG Changes from baseline to post-treatment
Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG)
Measured: Baseline vs 2 weeks and 6 months after treatment
fNIRS
functional near-infrared spectroscopy
Measured: Baseline vs 2 weeks and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start16 Apr 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324161
- Sponsor's protocol ID
- rTMS
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in the Treatment of Alzheimer's Disease and Exploration of Glymphatic Mechanisms
- ClinicalTrials.gov ID
- NCT07324161
- Acronym / sponsor ID
- rTMS
- Conditions
- Alzheimer s Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: rTMS |
| sham rTMS | Sham comparator | Device: sham rTMS |
| Accelerated rTMS | Active comparator | Device: Accelerated rTMS |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Contraindications to rTMS treatment
- Severe complications or immune diseases
- Unable to cooperate with study procedures
- History of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSStimulation 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. | Device | rTMS |
| sham rTMSStimulation 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 | Device | sham rTMS |
| Accelerated rTMSAccelerated 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. | Device | Accelerated rTMS |
Primary outcome
MoCA Changes from baseline to post-treatment
Time frame: Baseline vs 2 weeks and 6 months after treatment
Montreal Cognitive Assessment (MoCA)
7 secondary outcomes
CDR Changes from baseline to post-treatment
Time frame: Baseline vs 2 weeks and 6 months after treatment
ACE-III Changes from baseline to post-treatment
Time frame: 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
NPI Changes from baseline to post-treatment
Time frame: 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
TMS-EEG Changes from baseline to post-treatment
Time frame: Baseline vs 2 weeks and 6 months after treatment
fNIRS
Time frame: Baseline vs 2 weeks and 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and Accelerated rTMS in people with Alzheimer s Disease, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Pan (13395080173, panxd@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA Changes from baseline to post-treatment (time frame: Baseline vs 2 weeks and 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.