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

NCT05872243 | Unknown

• 1 other identifier: CPLXWAD2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Alzheimer's Disease

Keywords

TMS, fMRI, AD, personalized

Outcome Measures

Primary Outcomes (1)

• Post-treatment ADAS-Cog change

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

  Pretreatment (baseline), Post-treatment (15 days)

Secondary Outcomes (2)

• Follow-up ADAS-Cog change

  Pretreatment(baseline), follow-up (90 days)

• MMSE change

  Pretreatment(baseline), post-treatment(15 days), follow-up (90 days)

Other Outcomes (5)

• MoCA change

  Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)

• NPI change

  Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)

• AVLT change

  Pretreatment(baseline), post-treatment (15 days), follow-up (90 days)

Study Arms (4)

WMN group

EXPERIMENTAL

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

Device: active rTMS

DMN group

EXPERIMENTAL

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

Device: active rTMS

sham WMN group

SHAM COMPARATOR

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

Device: sham rTMS

sham DMN group

SHAM COMPARATOR

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

Device: sham rTMS

Interventions

active rTMS DEVICE

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; WMN group

sham rTMS DEVICE

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 WMN group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changping Laboratory: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

Study Officials

• HeSheng Liu, Ph.D.

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Na Xu, Ph.D.

CONTACT

+8618810069676; naxu@cpl.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 24, 2023
• Study Start: September 11, 2023
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CN (1)