Study Results
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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RECRUITING
NA
45 participants
INTERVENTIONAL
2023-09-11
2024-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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WMN group
Active rTMS will be delivered to the tailored stimulation site within the working memory network.
active rTMS
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.
DMN group
Active rTMS will be delivered to the tailored stimulation site within the default mode network.
active rTMS
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 WMN group
Sham rTMS will be delivered to the tailored stimulation site within the working memory network.
sham rTMS
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.
sham DMN group
Sham rTMS will be delivered to the tailored stimulation site within the default mode network.
sham rTMS
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.
Interventions
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active rTMS
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 rTMS
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
50 Years
90 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Changping Laboratory
OTHER
Responsible Party
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Principal Investigators
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HeSheng Liu, Ph.D.
Role: STUDY_CHAIR
Changping Laboratory
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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AoNan Li, M.D.
Role: primary
Other Identifiers
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CPLXWAD2023
Identifier Type: -
Identifier Source: org_study_id