Study on Novel Peripheral Blood Diagnostic Biomarkers for MCI Due to Alzheimer's Disease (Precision1000)

Shanghai Mental Health Center

Status: Unknown

Conditions: Alzheimer Disease

Treatments: Diagnostic Test: MicRNAs battery kits

Study type: Observational

Funder types: Other

Identifiers

NCT04509271

WT20200808

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,300 participants in 7 patient groups

Normal aged

Treatment:

Diagnostic Test: MicRNAs battery kits

MCI due to AD

Treatment:

Diagnostic Test: MicRNAs battery kits

Mild AD

Treatment:

Diagnostic Test: MicRNAs battery kits

Moderate AD

Treatment:

Diagnostic Test: MicRNAs battery kits

Severe AD

Treatment:

Diagnostic Test: MicRNAs battery kits

Dementia with Lewy body

Treatment:

Diagnostic Test: MicRNAs battery kits

Frontotemporal dementia

Treatment:

Diagnostic Test: MicRNAs battery kits