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Clinical Trials in China / NCT04575337
Recruiting Observational

Study on Biomarkers for Early Diagnosis of Alzheimer's Disease

NCT04575337 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Observational
Started
2020-05-28
Last updated
2026-03-23

Condition(s) studied

Alzheimer Disease

Study summary

The project of Bio-AD is a population- based cohort study among the elderly in China.

The project includes not only Alzheimer's disease (AD including familial AD and sporadic AD), but also other clinical stage of AD, as well as elderly people with normal cognitive function.

The project will collect, detect and screen the special biomarkers at different clinical stage of AD based on body fluid, gene and brain image. The standard and consistent assessment protocols are employed to obtain clinical, cognitive, genetic, neuroimaging and biospecimen data.

The purpose of this project is to establish a panel of biomarkers which could be used to diagnose AD at the early stage, and to establish a risk prediction models for AD to predict the 5-years risk of the onset and progression of AD among elderly population in China.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Written informed consent obtained from participant or legal guardian prior to any study-related procedures. * Aged 18 (inclusive) or older. * Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE, CDR and other cognitive function scales. * Follow up 5 years and collect the information. Exclusion Criteria: * Under age 18. * Medical or psychiatric illness that would interfere in completing initial and follow-up visits. * No one can serve as a study informant. * With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia. * Refused to complete a cognitive test and provide biospecimen. * With history of alcohol or drug abuse.

Primary outcome measure(s)

  • A multiple diagnostic kit for early diagnosis of AD. — An Average of 1 year
    A panel of special biomarkers is identified for early diagnosis of AD.
  • A 5-years risk prediction model for onset and progression of AD among elderly population in China. — An Average of 1 year
    A 5-years risk prediction model including multiple factors to predict the onset and progression of AD in China.

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital of Capital Medical University Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04575337 on ClinicalTrials.gov ↗ ← All trials in China