Effects of Cerebellar Transcranial Magnetic Stimulation on Patients With Alzheimer's Disease:A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Alzheimer's Disease (AD) is the primary cause of dementia, with its prominent feature being cognitive decline. The cerebellum plays a crucial role in cognitive processing, making it a potential target for therapeutic intervention. This study will be conducted to evaluate the efficacy and safety of cerebellar Intermittent theta-burst stimulation (CRB-iTBS) in participants with mild Alzheimer's disease on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 3 months of treatment in the Core Study. This project aims to provide a valid treatment to improve the cognitive function and quality of life for those with Alzheimer's disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• Age: 50-85 years old

• Meet the core clinical criteria of NIA-AA for possible Alzheimer's disease dementia, and PET or cerebrospinal fluid markers show elevated p-tau and decreased A β (1-42)

• MMSE score ranges from 18-26 points; CDR score 0.5-1 points

• The patient has received treatment with acetylcholinesterase inhibitors (AChEI), NMDA receptor antagonists, or mannequine therapy, and the current dosing regimen has remained stable for the 12 weeks prior to baseline assessment

• At least one adult caregiver

• The patient or legal guardian voluntarily signs the informed consent form

Locations
Other Locations
China
Tangdu Hospital of Air Force Military Medical University
RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Medical University
RECRUITING
Xi'an
The Third Hospital of Xi'an
RECRUITING
Xi'an
Xijing Hospital of Air Force Military Medical University
RECRUITING
Xi'an
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2026-04-10
Participants
Target number of participants: 100
Treatments
Active_comparator: Arms
Participants will receive iTBS-TMS once a day for 4 weeks, followed by once a week for 8 weeks.
Sham_comparator: Assigned Interventions
Participants will receive sham iTBS-TMS once a day for 4 weeks, followed by once a week for 8 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: First Affiliated Hospital Xi'an Jiaotong University, Tang-Du Hospital, Xi'an No.3 Hospital
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov