NCT04575337Recruiting
Study on Biomarkers for Early Diagnosis of Alzheimer's Disease
Study on Body Fluid, Gene and Neuroimaging Biomarkers for Early Diagnosis of Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 6000 (estimated)
- First submitted
- 29 Sept 2020
- Start date
- 28 May 2020
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Capital Medical University
- Diseases
- Alzheimer disease
- NCT number
- NCT04575337
What you commit to
- Study type: Observational
- Planned participants: 6000
- From 28 May 2020 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Medical or psychiatric illness that would interfere in completing initial and follow-up visits.
- With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia.
- With history of alcohol or drug abuse.
Age
- Under age 18.
Other
- No one can serve as a study informant.
- Refused to complete a cognitive test and provide biospecimen.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital of Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.