Actively Recruiting

Phase Not Applicable
Age: 50Years - 85Years
All Genders
NCT06669182

Advantage of Cerebellar Transcranial Magnetic Stimulation in Alzheimer's Diseases (ACT-AD)

Led by Xijing Hospital · Updated on 2025-11-24

100

Participants Needed

4

Research Sites

65 weeks

Total Duration

On this page

Sponsors

X

Xijing Hospital

Lead Sponsor

T

Tang-Du Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Advantage of Cerebellar Transcranial Magnetic Stimulation in Alzheimer's Diseases (ACT-AD)

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 85 years old
  • Meet core clinical criteria of NIA-AA for possible Alzheimer's disease dementia with elevated p-tau and decreased A b2 (1-42) confirmed by PET or cerebrospinal fluid markers
  • MMSE score between 18 and 26 points and CDR score between 0.5 and 1 points
  • Stable treatment with acetylcholinesterase inhibitors, NMDA receptor antagonists, or mannequine therapy for at least 12 weeks before baseline
  • Have at least one adult caregiver
  • Patient or legal guardian voluntarily signs informed consent form
Not Eligible

You will not qualify if you...

  • Diagnosis of neurodegenerative disorders other than Alzheimer's disease
  • Significant intracranial focal or vascular pathology seen on brain MRI
  • History of seizures excluding febrile seizures in childhood
  • Current major depressive disorder, schizophrenia, other psychotic disorders, bipolar disorder, or substance-related disorders within the past 5 years
  • GDS score of 8 or higher at baseline
  • Presence of cerebrovascular disease, severe infection, malignant tumor, or severe dysfunction of heart, liver, or kidney
  • Pregnant or lactating women
  • Contraindications for TMS or MRI such as implanted metal devices including pacemakers or deep brain stimulators
  • Participation in Alzheimer's disease-related clinical trials within 6 months prior to enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Xijing Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China, 710032

Actively Recruiting

2

Tangdu Hospital of Air Force Military Medical University

Xi'an, Shannxi, China

Actively Recruiting

3

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shannxi, China

Actively Recruiting

4

The Third Hospital of Xi'an

Xi'an, Shannxi, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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