NCT04509271

Study on Novel Peripheral Blood Diagnostic Biomarkers for MCI Due to Alzheimer's Disease

Shanghai Mental Health Center

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. Peripheral Blood biomarkers is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. Even Tau-181 and Tau-217 were reported in this year on Lancet neurology and JAMA. We also need to study on the biomarkers upstream of pathological changes about senile plaque. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD and other dementia such as DLB and FTLD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. Plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MicRNAs battery kits	Novel peripheral blood diagnostic biomarker for MCI due to AD.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-01-30
• Completion: 2022-09-30
• First posted: 2020-08-12
• Last updated: 2021-09-27

Locations

1 site across 1 country: China