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

Alzheimer's Disease Clinical Trial

Official title:

Shanghai Mental Health Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137926
• Other study ID #: CRC2019ZD03
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2020
• Source: Shanghai Mental Health Center
• Contact: Yifeng Shen, M.D.
• Phone: 00862164387250
• Email: shenyifeng[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

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%. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non AD dementia

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Diagnostic Test:
• MicRNAs battery
for MCI due to AD diagnosis

Locations

Country	Name	City	State
China	Department of Psychogeriatrics,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	MicRNAs battery for diagnostic of MCI due to AD	2 years
Primary	Neropsychological test battery	MicRNAs for intervene of MCI due to AD	2 years
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of participants with treatment-related adverse events as assessed by MicRNAs.	2 years