pBFS Guided rTMS Treating Mild Alzheimer's Disease(AD)

  • STATUS
    Recruiting
  • participants needed
    45
  • sponsor
    Changping Laboratory
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Updated on 24 January 2025
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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.

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.

Details
Condition Mild Alzheimer's Disease
Age 50years - 90years
Clinical Study IdentifierNCT05872243
SponsorChangping Laboratory
Last Modified on24 January 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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