Clinical trial Recruiting at 1 site Observational Ages 18 and up

Identifying biomarkers for early diagnosis of Alzheimer's disease

Official title: Study on Body Fluid, Gene and Neuroimaging Biomarkers for Early Diagnosis of Alzheimer's Disease

Run by Capital Medical University · NCT04575337 · Data updated 2026-11-12

This study is trying to find early signs of Alzheimer's disease by looking at a large group of older people in China to help diagnose and treat the condition sooner.

More Alzheimer Disease trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment6000 (estimated)
SponsorCapital Medical University
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMay 28, 2020
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedMarch 23, 2026
Trial IDNCT04575337 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are elderly individuals aged 18 and older, including those diagnosed with Alzheimer's disease, mild cognitive impairment, or those with normal cognitive function.

Probably not a fit

Patients under the age of 18 or those with significant medical or psychiatric illnesses may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to establish a large population-based cohort of elderly individuals in China, including those with Alzheimer's disease (AD), mild cognitive impairment (MCI), and normal cognitive function. It will collect clinical, cognitive, genetic, neuroimaging, and biospecimen data to identify specific biomarkers associated with different stages of AD. The study will also develop risk prediction models to forecast the onset and progression of AD over a five-year follow-up period. By employing standardized assessment protocols, the project seeks to enhance early diagnosis and intervention strategies for Alzheimer's disease.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of Alzheimer's disease, allowing for timely interventions.

How similar studies have gone: Other studies have shown promise in identifying biomarkers for Alzheimer's disease, but this approach focuses on a comprehensive population-based cohort, making it a novel effort.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Xuanwu Hospital of Capital Medical University
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.