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

Not Applicable

• Conditions: Alzheimer's Disease
• Interventions: Diagnostic Test: MicRNAs battery

• Registration Number: NCT04137926
• Lead Sponsor: Shanghai Mental Health Center

Brief 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%. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2020-03-01
• Status Verified: 2020-10
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-23
• Primary Completion: 2022-08-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

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

Exclusion Criteria

• Non AD dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alzheimer's disease	MicRNAs battery	-
MCI due to AD	MicRNAs battery	-
Normal Elderly	MicRNAs battery	-

Primary Outcome Measures

Name	Time	Method
the diagnostic accuracy of biomarkers for MCI due to AD	2 years	MicRNAs battery for diagnostic of MCI due to AD
Neropsychological test battery	2 years	MicRNAs for intervene of MCI due to AD

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	2 years	Number of participants with treatment-related adverse events as assessed by MicRNAs.

Trial Locations

Locations (1)

Department of Psychogeriatrics，Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China