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

Alzheimer Disease Clinical Trial

— Precision1000  

Official title:

Shanghai Mental Health Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04509271
• Other study ID #: WT20200808
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2021
• Source: Shanghai Mental Health Center
• Contact: Tao Wang, M.D., Ph.D.
• Phone: +862164387250
• Email: wtshhwy[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: September 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• 2011 NIA-AA criteria of MCI due to AD or AD or - 2017 Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium or - 2001 the McKhann consensus clinical criteria for FTD (McKhann et al.)

Exclusion Criteria:

• Dementia caused by infection or substance

• Thyroid disease

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Diagnostic Test:
• MicRNAs battery kits
Novel peripheral blood diagnostic biomarker for MCI due to AD.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy of biomarkers for MCI due to AD and other dementia.	MicRNAs battery for diagnostic of MCI due to AD	1 and half years