search
Back to results

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

Primary Purpose

Mild Alzheimer's Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active rTMS
sham rTMS
Sponsored by
Changping Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Alzheimer's Disease focused on measuring TMS, fMRI, AD, personalized

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of probable Alzheimer's disease (probable AD) based on the AD diagnostic criteria proposed by NIA-AA. Positive results on amyloid PET imaging. Elementary school education or higher. MMSE scores between 20 and 25 (or 18 and 25 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Sham Comparator

    Arm Label

    WMN group

    DMN group

    sham WMN group

    sham DMN group

    Arm Description

    Active rTMS will be delivered to the tailored stimulation site within the working memory network.

    Active rTMS will be delivered to the tailored stimulation site within the default mode network.

    Sham rTMS will be delivered to the tailored stimulation site within the working memory network.

    Sham rTMS will be delivered to the tailored stimulation site within the default mode network.

    Outcomes

    Primary Outcome Measures

    Post-treatment ADAS-Cog change
    The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to post-treatment.

    Secondary Outcome Measures

    Follow-up ADAS-Cog change
    The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to follow-up
    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).

    Full Information

    First Posted
    May 14, 2023
    Last Updated
    May 14, 2023
    Sponsor
    Changping Laboratory
    Collaborators
    Xuanwu Hospital, Beijing
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05872243
    Brief Title
    pBFS Guided rTMS Treating Mild Alzheimer's Disease(AD)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 30, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changping Laboratory
    Collaborators
    Xuanwu Hospital, Beijing

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to investigate the effectiveness and safety of rTMS treatment under the guidance of personalized Brain Functional Sectors (pBFS) in improving 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Alzheimer's Disease
    Keywords
    TMS, fMRI, AD, personalized

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    WMN group
    Arm Type
    Experimental
    Arm Description
    Active rTMS will be delivered to the tailored stimulation site within the working memory network.
    Arm Title
    DMN group
    Arm Type
    Experimental
    Arm Description
    Active rTMS will be delivered to the tailored stimulation site within the default mode network.
    Arm Title
    sham WMN group
    Arm Type
    Sham Comparator
    Arm Description
    Sham rTMS will be delivered to the tailored stimulation site within the working memory network.
    Arm Title
    sham DMN group
    Arm Type
    Sham Comparator
    Arm Description
    Sham rTMS will be delivered to the tailored stimulation site within the default mode network.
    Intervention Type
    Device
    Intervention Name(s)
    active rTMS
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    sham rTMS
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Post-treatment ADAS-Cog change
    Description
    The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to post-treatment.
    Time Frame
    Pretreatment (baseline), Post-treatment (15 days)
    Secondary Outcome Measure Information:
    Title
    Follow-up ADAS-Cog change
    Description
    The Cognitive Subscale score change of the Alzheimer's Disease Assessment Scale, from baseline to follow-up
    Time Frame
    Pretreatment(baseline), follow-up (90 days)
    Title
    MMSE change
    Description
    Change in Mini-Mental State Examination (MMSE) scores at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
    Time Frame
    Pretreatment(baseline), post-treatment(15 days), follow-up (90 days)
    Other Pre-specified Outcome Measures:
    Title
    MoCA change
    Description
    Change in Montreal Cognitive Assessment (MoCA) scores at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
    Time Frame
    Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
    Title
    NPI change
    Description
    Change in Neuropsychiatric Inventory scores at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
    Time Frame
    Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
    Title
    CDR change
    Description
    Change in Clinical Dementia Rating(CDR) scores at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
    Time Frame
    Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
    Title
    AVLT change
    Description
    Change in Auditory Verbal Learning Test (AVLT) at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
    Time Frame
    Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
    Title
    TMT change
    Description
    Change in Trail Making Test (TMT)at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
    Time Frame
    Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)
    Title
    Digit span change
    Description
    Change in Digit span at post-treatment (15 days) and follow-up (90 days) compared to baseline assessment (0 days).
    Time Frame
    Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of probable Alzheimer's disease (probable AD) based on the AD diagnostic criteria proposed by NIA-AA. Positive results on amyloid PET imaging. Elementary school education or higher. MMSE scores between 20 and 25 (or 18 and 25 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yifei Zhang, Ph.D.
    Phone
    +8613581683950
    Email
    yifei.zhang@cpl.ac.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    HeSheng Liu, Ph.D.
    Organizational Affiliation
    Changping Laboratory
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs