NCT04575337

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

1. Set up a large population- based cohort including AD, MCI, pre-MCI, other neurodegenerative diseases, and elderly individuals with normal cognitive function. 2. Collect the information of clinical and neuropsychological assessment, individual traits and social environmental factors, and neuroimaging data, as well as the biological samples, such as peripheral blood and cerebrospinal fluid. 3. Screen biomarkers with high specificity and sensitivity from peripheral blood, cerebrospinal fluid and neuroimaging to distinguish different clinical stages of AD at baseline. 4. Screen the AD-associated gene and their risk variants. 5. Establish a panel of AD-specific biomarkers for the preliminary development of diagnostic kit. 6. Identify AD-relevant factors and the special biomarkers to create a preliminary risk models to predict the onset and progression of AD. 7. Follow up the cohort for next 5 years and collect the multiple information and biological samples each year to validate and revise the risk prediction models and the diagnostic kit of AD.

Conditions

• Alzheimer Disease

Timeline

• Start date: 2020-05-28
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2020-10-05
• Last updated: 2026-03-23

Locations

1 site across 1 country: China