Actively Recruiting
Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging
Led by Huashan Hospital · Updated on 2025-06-05
3000
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to investigate neuroimage and biomarkers in the Alzheimer's continuum in Chinese population. We aimed to: * To reveal the progress of AD by multiple neuroimage and biomarkers; * To reveal the longitudinal change of biomarkers and cognition of AD in Chinese population; * To investigate the interaction of markers between body and brain; * To set up new markers by neuroimage.
CONDITIONS
Official Title
Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 45 and 90 years, no gender restrictions
- Cognitive unimpaired participants have normal cognitive function with a Clinical Dementia Rating (CDR) score of 0
- No neurological diseases, major chronic illnesses, malignant tumors, or acute infectious diseases
- No family history of Alzheimer's disease or other neurological diseases related to cognitive impairment or movement disorders
- Able to understand and provide written informed consent
- Female subjects must have surgical sterilization documentation or be menopausal for over one year; if of childbearing potential, must use effective contraception during study
- Male subjects must use effective contraception during study and not donate sperm during this time
- Willing and able to comply with all study procedures
- Cognitive impaired patients aged 45 to 90 years with CDR score ≥ 0.5
- Mini-Mental State Examination (MMSE) score ≤ 24
- Brain MRI findings support Alzheimer's disease diagnosis without other neurological diseases
- Medications for Alzheimer's symptoms must be stable for at least 30 days before participation
- Written informed consent provided by subject or legal guardian/caregiver
- Subjects may be accompanied by a caregiver if necessary
You will not qualify if you...
- Severe neurological diseases or serious disorders affecting gastrointestinal, cardiovascular, hepatic, renal, hematologic, oncologic, endocrine, respiratory, or immune systems
- MRI-incompatible metal implants such as pacemakers, intravascular metal devices, insulin pumps, cochlear implants, nerve stimulators, or cerebral aneurysm clips
- Inability to tolerate MRI noise or history of claustrophobia
- Exposure to ionizing radiation over 50 mSv within the past year due to other research participation
- History of drug or alcohol abuse
- Pregnancy or lactation
- Poor venous access preventing repeated venipuncture
- Use of experimental drugs or devices with unknown safety or efficacy within the past month
- Allergy to any components of the tracer injection
- Any condition posing risk or compromising study integrity as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yihui Guan, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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