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Search / Trial NCT04042532

Theta-burst Stimulation on Cognitive Function in the Patients with Young-onset Alzheimer's Disease Dementia

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jul 31, 2019

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Young Onset Dementia Alzheimer's Disease R Tms Tbs

ClinConnect Summary

The investigators apply the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria to recruit the biomarker-defined, young-onset AD patients with intermediate-to-high levels of biological evidence. This is a randomized, sham-controlled, 2-way crossover study, and combined neuroimaging study of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) to further explore the potential mechanisms. This study will consist of two intervention periods. A total of 50 young-onset AD patients will be consecutively recruited and be randomized into o...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Any patient has a definite diagnosis of AD dementia according to the NIA-AA criteria for intermediate-to-high levels of biological evidence of probable and possible AD dementia (McKhann et al. 2011).
  • 2. Dementia onset before age 65 years old.
  • 3. Age between 50-75 years old for patient and control group.
  • 4. The severity of dementia is limited to mild to moderate stage in current project. The definition of mild to moderate stage of dementia is based on the clinical dementia rating scale (CDR) from 0.5-2.
  • 5. Cognitively normal controls MMSE≧24, CDR should be 0.
  • 6. Informed consent provided by the patient and family.
  • Exclusion Criteria:
  • 1. Any subject has a definite diagnosis of epilepsy or history of seizure attack.
  • 2. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
  • 3. Any subject has clinically significant or unstable medical diseases including metabolic, renal, liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders
  • 4. Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or previously prolonged history of substances abuse
  • 5. Any females who is pregnant or lactating
  • 6. General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not magnetic resonance (MR) compatible in the body.
  • 7. Any subject has allergic reaction to 18F-florbetapir or 18F-FDG radiotracers.

About Chang Gung Memorial Hospital

Chang Gung Memorial Hospital, one of the largest healthcare organizations in Taiwan, is renowned for its commitment to advancing medical research and improving patient care. As a clinical trial sponsor, the hospital leverages its extensive clinical expertise and state-of-the-art facilities to conduct innovative research across various medical disciplines. With a focus on collaboration and ethical practices, Chang Gung Memorial Hospital aims to contribute to the global body of medical knowledge through rigorous clinical trials that enhance treatment options and improve health outcomes for patients.

Locations

Taoyuan, Guishan, Taiwan

Patients applied

0 patients applied

Trial Officials

KUAN YI WU

Principal Investigator

Chang Gung Memorial Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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