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%. 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,300

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2020

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

August 9, 2020

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed

2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed

Last Updated

September 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 9, 2020

Last Update Submit

September 21, 2021

Conditions

Alzheimer Disease

Outcome Measures