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

November 30, 2023 updated by: Changping Laboratory

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Na Xu, Ph.D.
  • Phone Number: +8618810069676
  • Email: naxu@cpl.ac.cn

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • AoNan Li, M.D.
          • Phone Number: +8613661339557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WMN group
Active rTMS will be delivered to the tailored stimulation site within the working memory network.
Device: 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.
Experimental: DMN group
Active rTMS will be delivered to the tailored stimulation site within the default mode network.
Device: 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 Comparator: sham WMN group
Sham rTMS will be delivered to the tailored stimulation site within the working memory network.
Device: 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 Comparator: sham DMN group
Sham rTMS will be delivered to the tailored stimulation site within the default mode network.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pretreatment (baseline), Post-treatment (15 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up ADAS-Cog change
Time Frame: Pretreatment(baseline), follow-up (90 days)
The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to follow-up
Pretreatment(baseline), follow-up (90 days)
MMSE change
Time Frame: Pretreatment(baseline), post-treatment(15 days), follow-up (90 days)
Change in Mini-Mental State Examination (MMSE) scores at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
Pretreatment(baseline), post-treatment(15 days), follow-up (90 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA change
Time Frame: Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
Change in Montreal Cognitive Assessment (MoCA) scores at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
NPI change
Time Frame: Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
Change in Neuropsychiatric Inventory scores at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
AVLT change
Time Frame: Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
Change in Auditory Verbal Learning Test (AVLT) at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
TMT change
Time Frame: Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
Change in Trail Making Test (TMT)at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
Digit span change
Time Frame: Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
Change in Digit span at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changping Laboratory

Collaborators

Xuanwu Hospital, Beijing

Investigators

  • Study Chair: Hesheng Liu, Ph.D., Changping Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

May 14, 2023

First Submitted That Met QC Criteria

May 14, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPLXWAD2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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