Mild Alzheimer's DiseaseNCT05872243
pBFS Guided rTMS Treating Mild Alzheimer's Disease(AD)
A study testing active rTMS in people with Mild Alzheimer's Disease, run by Changping Laboratory at 1 site in China.
Trial summary
This study aims to investigate the effectiveness and safety of rTMS treatment under the guidance of personalized Brain Functional Sectors (pBFS) for the cognitive ability of patients with mild Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Alzheimer's Disease
- What is being tested?
- active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2023to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of probable Alzheimer's disease (probable AD) based on the AD diagnostic criteria proposed by NIA-AA.
- Positive PET or positive cerebrospinal fluid test results for beta-amyloid (Aβ).
- Elementary school education or higher.
- MMSE scores between 20 and 26 (including 20 and 26), or 18 and 26 for those with elementary school education.
- Clinical Dementia Scale (CDR) score of 1, indicating mild dementia.
- Stable medication for Alzheimer's disease for at least 3 months prior to treatment.
- Availability of a reliable caregiver who can assist and accompany the patient throughout the study.
- Voluntary participation with signed informed consent by the patient or legal guardian.
Who cannot join
- Patients who have other causes of cognitive decline apart from AD, including but not limited to vascular dementia, Parkinson's disease dementia, dementia with Lewy bodies, frontotemporal dementia, and dementia due to endocrine system lesions or deficiencies of folic acid, vitamin B12 or other causes.
- Patients with significant focal lesions seen on MRI, including more than two infarct foci larger than 2 cm in diameter, infarct foci in key areas such as the thalamus, hippocampus, internal olfactory cortex, pars oligo-cortical, angular gyrus, cortical and other subcortical gray matter nuclei.
- Patients with moderate to severe cerebral white matter degeneration ( Fazekas score of 3-6).
- Patients unable to undergo TMS treatment or MRI scan due to metallic foreign bodies, implanted electronic devices, or claustrophobia.
- Patients with a history of seizures or epilepsy syndrome, or seizures within the past 12 months.
- Patients with acute cardiovascular and cerebrovascular events within the 3 months prior to screening.
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- Patients with severe cardiac, pulmonary, hepatic, renal, and other systemic diseases that cannot be controlled with conventional medications.
- Patients with malignant tumors or a life expectancy of less than 1 year due to reasons other than AD.
- History of alcohol or drug abuse.
- Having received other TMS treatments within the past three months.
- Having participated, or is currently participating in other clinical trial programs within the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-blind, Controlled Trial of rTMS in the Treatment of Mild Alzheimer's Disease Guided by Personalized Brain Functional Sectors(pBFS)
This study aims to investigate the effectiveness and safety of rTMS treatment under the guidance of personalized Brain Functional Sectors (pBFS) for the cognitive ability of patients with mild Alzheimer's disease.
Read the detailed description
Alzheimer's Disease (AD) is a neurodegenerative disorder characterized by memory impairment and cognitive decline. Personalized brain functional sectors (pBFS) using resting-state functional MRI scans have shown promise in precisely identifying individualized brain function networks. In this study, we aim to select tailored stimulation sites within the working memory network (WMN) or the default mode network (DMN) as intervention targets for mild AD patients using pBFS.
To evaluate the effectiveness and safety of this intervention, participants will be randomized into four groups: active repetitive transcranial magnetic stimulation (rTMS) to the WMN group, active rTMS to the DMN group, and sham rTMS to either the WMN or DMN group at a ratio of 2:2:1:1. Each participant will receive 3600 pulse active or sham rTMS in each session, consisting of two 1800 pulse treatments with a 50-minute break in between. Two separate treatment sessions will be administered daily, resulting in a sum of 7200 pulses per day. The intervention will be administered for 15 continuous days.
- Conditions
- Mild Alzheimer's Disease
- Being tested
- active rTMS, sham rTMS
- Keywords
- TMS, fMRI, AD, personalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMSDevice
Each participant will receive two 1800 pulse active rTMS in each session, with a 50-minute break in between. Participants will receive two separate sessions daily (a sum of 7200 pulses per day). The intervention will take place for 15 continuous days.
sham rTMSDevice
Each participant will receive two 1800 pulse sham rTMS in each session, with a 50-minute break in between. Participants will receive two separate sessions daily (a sum of 7200 pulses per day). The intervention will take place for 15 continuous days.
| Study group | Role | What they receive |
|---|---|---|
| WMN group | Experimental | Active rTMS will be delivered to the tailored stimulation site within the working memory network. Receives: Device: active rTMS |
| DMN group | Experimental | Active rTMS will be delivered to the tailored stimulation site within the default mode network. Receives: Device: active rTMS |
| sham WMN group | Sham comparator | Sham rTMS will be delivered to the tailored stimulation site within the working memory network. Receives: Device: sham rTMS |
| sham DMN group | Sham comparator | Sham rTMS will be delivered to the tailored stimulation site within the default mode network. Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment ADAS-Cog change
The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to post-treatment.
Measured: Pretreatment (baseline), Post-treatment (15 days)
Secondary outcomes (2)
Follow-up ADAS-Cog change
The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to follow-up
Measured: Pretreatment(baseline), follow-up (90 days)
MMSE change
Change in Mini-Mental State Examination (MMSE) scores at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
Measured: Pretreatment(baseline), post-treatment(15 days), follow-up (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start5 Sep 2023
- Primary completion13 Dec 2024
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
- Investigators
- HeSheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872243
- Sponsor's protocol ID
- CPLXWAD2023
- Status last verified
- Jun 2026
- First submitted
- 14 May 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Controlled Trial of rTMS in the Treatment of Mild Alzheimer's Disease Guided by Personalized Brain Functional Sectors(pBFS)
- ClinicalTrials.gov ID
- NCT05872243
- Acronym / sponsor ID
- CPLXWAD2023
- Conditions
- Mild Alzheimer's Disease
- Keywords
- TMS, fMRI, AD, personalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 24 May 2023 (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 aims to investigate the effectiveness and safety of rTMS treatment under the guidance of personalized Brain Functional Sectors (pBFS) for the cognitive ability of patients with mild Alzheimer's disease.
Detailed description
Alzheimer's Disease (AD) is a neurodegenerative disorder characterized by memory impairment and cognitive decline. Personalized brain functional sectors (pBFS) using resting-state functional MRI scans have shown promise in precisely identifying individualized brain function networks. In this study, we aim to select tailored stimulation sites within the working memory network (WMN) or the default mode network (DMN) as intervention targets for mild AD patients using pBFS.
To evaluate the effectiveness and safety of this intervention, participants will be randomized into four groups: active repetitive transcranial magnetic stimulation (rTMS) to the WMN group, active rTMS to the DMN group, and sham rTMS to either the WMN or DMN group at a ratio of 2:2:1:1. Each participant will receive 3600 pulse active or sham rTMS in each session, consisting of two 1800 pulse treatments with a 50-minute break in between. Two separate treatment sessions will be administered daily, resulting in a sum of 7200 pulses per day. The intervention will be administered for 15 continuous days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WMN group | Experimental | Device: active rTMSActive rTMS will be delivered to the tailored stimulation site within the working memory network. |
| DMN group | Experimental | Device: active rTMSActive rTMS will be delivered to the tailored stimulation site within the default mode network. |
| sham WMN group | Sham comparator | Device: sham rTMSSham rTMS will be delivered to the tailored stimulation site within the working memory network. |
| sham DMN group | Sham comparator | Device: sham rTMSSham rTMS will be delivered to the tailored stimulation site within the default mode network. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of probable Alzheimer's disease (probable AD) based on the AD diagnostic criteria proposed by NIA-AA.
- Positive PET or positive cerebrospinal fluid test results for beta-amyloid (Aβ).
- Elementary school education or higher.
- MMSE scores between 20 and 26 (including 20 and 26), or 18 and 26 for those with elementary school education.
- Clinical Dementia Scale (CDR) score of 1, indicating mild dementia.
Key exclusion criteria (11 listed)
- Patients who have other causes of cognitive decline apart from AD, including but not limited to vascular dementia, Parkinson's disease dementia, dementia with Lewy bodies, frontotemporal dementia, and dementia due to endocrine system lesions or deficiencies of folic acid, vitamin B12 or other causes.
- Patients with significant focal lesions seen on MRI, including more than two infarct foci larger than 2 cm in diameter, infarct foci in key areas such as the thalamus, hippocampus, internal olfactory cortex, pars oligo-cortical, angular gyrus, cortical and other subcortical gray matter nuclei.
- Patients with moderate to severe cerebral white matter degeneration ( Fazekas score of 3-6).
- Patients unable to undergo TMS treatment or MRI scan due to metallic foreign bodies, implanted electronic devices, or claustrophobia.
- Patients with a history of seizures or epilepsy syndrome, or seizures within the past 12 months.
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 |
|---|---|---|
| active rTMSEach participant will receive two 1800 pulse active rTMS in each session, with a 50-minute break in between. Participants will receive two separate sessions daily (a sum of 7200 pulses per day). The intervention will take place for 15 continuous days. | Device | DMN group, WMN group |
| sham rTMSEach participant will receive two 1800 pulse sham rTMS in each session, with a 50-minute break in between. Participants will receive two separate sessions daily (a sum of 7200 pulses per day). The intervention will take place for 15 continuous days. | Device | sham DMN group, sham WMN group |
Primary outcome
Post-treatment ADAS-Cog change
Time frame: Pretreatment (baseline), Post-treatment (15 days)
The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to post-treatment.
2 secondary outcomes
Follow-up ADAS-Cog change
Time frame: Pretreatment(baseline), follow-up (90 days)
MMSE change
Time frame: Pretreatment(baseline), post-treatment(15 days), follow-up (90 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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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. This study is not recruiting at the moment.
HeSheng Liu, Ph.D. study chair
Changping Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS in people with Mild Alzheimer's Disease, run by Changping Laboratory 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment ADAS-Cog change (time frame: Pretreatment (baseline), Post-treatment (15 days)). 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 11 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.