A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease

Shanghai Mental Health Center

Status: Unknown

Conditions: Alzheimer's Disease

Treatments: Diagnostic Test: MicRNAs battery

Study type: Interventional

Funder types: Other

Identifiers

NCT04137926

CRC2019ZD03

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%. 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. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD. 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. [18F]-AV-45 plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD. Next, a pilot intervention study on APP/PS1 transgenic mice will be promoted based on miRNAs gene regulation.

Enrollment: 360 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 2011 NIA-AA criteria of MCI due to AD or AD

Exclusion criteria

• Non AD dementia

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 3 patient groups

Alzheimer's disease

Experimental group

Treatment:

Diagnostic Test: MicRNAs battery

MCI due to AD

Experimental group

Treatment:

Diagnostic Test: MicRNAs battery

Normal Elderly

Experimental group

Treatment:

Diagnostic Test: MicRNAs battery