NCT04575337 · RECRUITING

Study on Biomarkers for Early Diagnosis of Alzheimer's Disease

This is an observational study based in China that is tracking elderly people over five years to identify early biological markers of Alzheimer's disease. Researchers are collecting blood, genetic, and brain imaging data across a range of participants — from cognitively normal to diagnosed AD — hoping to build better early-detection tools and a model that predicts five-year risk. No phase is listed because no drug or device is being tested.

You may qualify if

  • 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.

You're excluded if

  • 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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-03-23

View full record on ClinicalTrials.gov

All APOE4 clinical trials