Alzheimer's DiseaseNCT07346794
The Underlying Neural Mechanism of TMS in Improving the Imbalance of "Microbiota-brain-gut Axis" in Alzheimer 's Disease Population
A study testing TMS in people with Alzheimer's Disease and rTMS Stimulation, run by Second Affiliated Hospital of Nanchang University.
Trial summary
What is this study about? This study focuses on Alzheimer's Disease (AD), a common neurodegenerative disease that affects memory, thinking, and daily life. We aim to explore whether a non-invasive treatment called Repetitive Transcranial Magnetic Stimulation (rTMS) can improve AD symptoms by regulating the… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, rTMS Stimulation
- What is being tested?
- TMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2026to 30 Sep 2030
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dementia Patients: Conformed to internationally recognized diagnostic criteria for dementia (e.g., DSM-5, NINCDS-ADRDA)
- Diagnosed through clinical evaluation, neuropsychological scale assessments, and relevant examinations
- Aged ≥50 years and residing in Nanchang, Jiangxi
- With dementia-negative family history, no severe psychiatric or neurological disorders
- No history of major systemic diseases.
Who cannot join
- Unable to cooperate with all required examinations, intervention procedures, and sample collection during the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
What is this study about? This study focuses on Alzheimer's Disease (AD), a common neurodegenerative disease that affects memory, thinking, and daily life. We aim to explore whether a non-invasive treatment called Repetitive Transcranial Magnetic Stimulation (rTMS) can improve AD symptoms by regulating the "gut-brain-intestine axis" - a connection between gut bacteria, the brain, and the intestines.
Who can participate?
Read more
- AD patients: Aged 50-80, diagnosed with mild to moderate AD (MMSE score 18-27, MoCA score 10-26), with stable condition for at least 6 months, and able to cooperate with tests and treatment.
- Healthy controls: Aged 50-80, with normal cognitive function (MMSE ≥28, MoCA ≥27), no AD family history, and matched in age and gender with AD patients.
Those with epilepsy, severe mental illness, recent use of antibiotics/probiotics, or inability to complete MRI scans are not eligible.
What will participants experience?
- AD patients: Will be randomly divided into two groups. Both groups will receive 4 weeks of treatment (5 days/week) with a helmet-like device. One group gets real rTMS (safe magnetic stimulation to the brain), and the other gets sham stimulation (no effective magnetic field, but same sound/feel).
- Healthy controls: No treatment, but will complete the same tests as AD patients.
- Tests during the study: Cognitive assessments (memory, thinking skills via questionnaires), stool/blood sample collection (to check gut bacteria and body markers), and MRI scans (to look at brain structure/function) at baseline, 1 month, 3 months, 6 months, and 1 year.
What are the potential benefits?
- Free rTMS treatment (for AD patients), free MRI scans (valued at 700 RMB), and a 200 RMB subsidy.
- Free health checks (gut bacteria analysis, metabolic tests) and cognitive evaluations to understand personal health status.
- Contribution to developing new AD treatments that may help future patients.
Is it safe? rTMS is a clinically proven safe technique. Possible mild side effects (headache, scalp irritation) usually go away on their own. Sample collection (stool/blood) and MRI scans are non-invasive or minimally invasive. A professional team will monitor participants throughout to handle any issues.
For healthcare providers This is a multicenter, randomized, double-blind sham-controlled study (200 AD patients, 200 healthy controls). The primary goal is to explore rTMS's mechanism via the gut-brain-intestine axis, with MoCA score changes (6 months post-treatment) as the main outcome. It integrates multi-omics and neuroimaging data to provide evidence for AD's non-drug treatment.
- Conditions
- Alzheimer's Disease, rTMS Stimulation
- Being tested
- TMS
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSProcedure or surgery
For the repetitive transcranial magnetic stimulation (rTMS) intervention, the dorsolateral prefrontal cortex (DLPFC) is selected as the stimulation target, with a stimulation frequency of 10 Hz; the intervention consists of 20 stimulation trains per day, 5 days per week, using a coil with a diameter of 9 cm, at an intensity of 80% of the motor threshold (minimum single-pulse intensity: 50 μV); each stimulation train lasts for 10 seconds, with an interval of 25 seconds between trains, and 20 trains per day totaling 2000 pulses. The treatment is administered once daily, five times a week, for 4 consecutive weeks, resulting in a total of 20 to 30 sessions, and the traditional "5-centimeter" method is adopted for localizing the DLPFC stimulation target.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing treatment | Experimental | Not described Receives: Procedure: TMS |
| No treatment | No intervention | The sham DLPFC-rTMS group will receive stimulation via a single helmet equipped with a sham coil, which is designed to induce similar noise and scalp sensations under the same parameters as the active stimulation group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA score
The Montreal Cognitive Assessment (MoCA) is a widely used tool for screening mild cognitive impairment (MCI), and its scoring reflects an individual's performance in cognitive domains such as attention, memory, and language. The total score is 30; a score of ≥26 is generally considered normal, 18-25 indicates mild cognitive impairment, and ≤17 may indicate moderate to severe impairment. Higher scores in the intervention group indicate better intervention effects.
Measured: Pre-intervention, Periprocedural, and Post-intervention at 1/3/6/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start21 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2030 (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 Second Affiliated Hospital of Nanchang UniversityThe 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
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346794
- Sponsor's protocol ID
- TMS82460341
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 9 Apr 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Underlying Neural Mechanism of TMS in Improving the Imbalance of "Microbiota-brain-gut Axis" in Alzheimer 's Disease Population
- ClinicalTrials.gov ID
- NCT07346794
- Acronym / sponsor ID
- TMS82460341
- Conditions
- Alzheimer's Disease, rTMS Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 21 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 16 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.
What is this study about? This study focuses on Alzheimer's Disease (AD), a common neurodegenerative disease that affects memory, thinking, and daily life. We aim to explore whether a non-invasive treatment called Repetitive Transcranial Magnetic Stimulation (rTMS) can improve AD symptoms by regulating the "gut-brain-intestine axis" - a connection between gut bacteria, the brain, and the intestines.
Who can participate?
- AD patients: Aged 50-80, diagnosed with mild to moderate AD (MMSE score 18-27, MoCA score 10-26), with stable condition for at least 6 months, and able to cooperate with tests and treatment.
- Healthy controls: Aged 50-80, with normal cognitive function (MMSE ≥28, MoCA ≥27), no AD family history, and matched in age and gender with AD patients.
Those with epilepsy, severe mental illness, recent use of antibiotics/probiotics, or inability to complete MRI scans are not eligible.
What will participants experience?
- AD patients: Will be randomly divided into two groups. Both groups will receive 4 weeks of treatment (5 days/week) with a helmet-like device. One group gets real rTMS (safe magnetic stimulation to the brain), and the other gets sham stimulation (no effective magnetic field, but same sound/feel).
- Healthy controls: No treatment, but will complete the same tests as AD patients.
- Tests during the study: Cognitive assessments (memory, thinking skills via questionnaires), stool/blood sample collection (to check gut bacteria and body markers), and MRI scans (to look at brain structure/function) at baseline, 1 month, 3 months, 6 months, and 1 year.
What are the potential benefits?
- Free rTMS treatment (for AD patients), free MRI scans (valued at 700 RMB), and a 200 RMB subsidy.
- Free health checks (gut bacteria analysis, metabolic tests) and cognitive evaluations to understand personal health status.
- Contribution to developing new AD treatments that may help future patients.
Is it safe? rTMS is a clinically proven safe technique. Possible mild side effects (headache, scalp irritation) usually go away on their own. Sample collection (stool/blood) and MRI scans are non-invasive or minimally invasive. A professional team will monitor participants throughout to handle any issues.
For healthcare providers This is a multicenter, randomized, double-blind sham-controlled study (200 AD patients, 200 healthy controls). The primary goal is to explore rTMS's mechanism via the gut-brain-intestine axis, with MoCA score changes (6 months post-treatment) as the main outcome. It integrates multi-omics and neuroimaging data to provide evidence for AD's non-drug treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing treatment | Experimental | Procedure: TMS |
| No treatment | No intervention | –The sham DLPFC-rTMS group will receive stimulation via a single helmet equipped with a sham coil, which is designed to induce similar noise and scalp sensations under the same parameters as the active stimulation group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dementia Patients: Conformed to internationally recognized diagnostic criteria for dementia (e.g., DSM-5, NINCDS-ADRDA)
- Diagnosed through clinical evaluation, neuropsychological scale assessments, and relevant examinations
- Aged ≥50 years and residing in Nanchang, Jiangxi
- With dementia-negative family history, no severe psychiatric or neurological disorders
- No history of major systemic diseases.
Key exclusion criteria (1 listed)
- Unable to cooperate with all required examinations, intervention procedures, and sample collection during the study.
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 |
|---|---|---|
| TMSFor the repetitive transcranial magnetic stimulation (rTMS) intervention, the dorsolateral prefrontal cortex (DLPFC) is selected as the stimulation target, with a stimulation frequency of 10 Hz; the intervention consists of 20 stimulation trains per day, 5 days per week, using a coil with a diameter of 9 cm, at an intensity of 80% of the motor threshold (minimum single-pulse intensity: 50 μV); each stimulation train lasts for 10 seconds, with an interval of 25 seconds between trains, and 20 trains per day totaling 2000 pulses. The treatment is administered once daily, five times a week, for 4 consecutive weeks, resulting in a total of 20 to 30 sessions, and the traditional "5-centimeter" method is adopted for localizing the DLPFC stimulation target. | Procedure or surgery | Patients undergoing treatment |
Primary outcome
MoCA score
Time frame: Pre-intervention, Periprocedural, and Post-intervention at 1/3/6/12 months
The Montreal Cognitive Assessment (MoCA) is a widely used tool for screening mild cognitive impairment (MCI), and its scoring reflects an individual's performance in cognitive domains such as attention, memory, and language. The total score is 30; a score of ≥26 is generally considered normal, 18-25 indicates mild cognitive impairment, and ≤17 may indicate moderate to severe impairment. Higher scores in the intervention group indicate better intervention effects.
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 9 Apr 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.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Alzheimer's Disease and rTMS Stimulation, run by Second Affiliated Hospital of Nanchang University.
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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Xijian Dai, Doctor (+86 13755756959, daixjdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA score (time frame: Pre-intervention, Periprocedural, and Post-intervention at 1/3/6/12 months). 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 9 Apr 2026.